Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- K242969Pantera Pro; Pantera LEO2Cleared 510(K)
- K233499Sapphire NC ULTRA Coronary Dilatation Catheter2Cleared 510(K)
- K233505Sapphire ULTRA Coronary Dilatation Catheter2Cleared 510(K)
- K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (582Cleared 510(K)
- K223189Firefighter™ NC Pro PTCA Balloon Catheter2Cleared 510(K)
- K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)2Cleared 510(K)
- K230705POT PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K223022SC HONKYTONK PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K220634NC TREK NEO Coronary Dilatation Catheter2Cleared 510(K)
- K220629Emerge Monorail PTCA Dilatation Catheter2Cleared 510(K)
- K212393OPN NC PTCA Dilatation Catheter2Cleared 510(K)
- K211349Selebrek PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K211807Sapphire NC 242Cleared 510(K)
- K210012Tamarin Blue PTCA RX Dilatation Catheter2Cleared 510(K)
- K211393Selethru(TM) NC PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K202578KardiFlex NC Coronary Dilatation Catheter2Cleared 510(K)
- K202619KardiFlex PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K203390Artimes pro Balloon Dilatation Catheter2Cleared 510(K)
- K200269Sapphire II PRO2Cleared 510(K)
- K192344Sapphire NC Plus Coronary Dilatation Catheter2Cleared 510(K)
- K182699Selethru PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter2Cleared 510(K)
- K180921Sapphire II PRO Balloon Dilatation Catheter2Cleared 510(K)
- K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K172264OTW Takeru PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K173680Sapphire II PRO2Cleared 510(K)
- K173581Gallant PTCA Dilatation Catheter2Cleared 510(K)
- K170941RX NC Takeru PTCA Balloon Dilatation Catheter2Cleared 510(K)
- K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters2Cleared 510(K)
- K163372RX Takeru Balloon Dilatation Catheter2Cleared 510(K)
- K163660Pantera LEO2Cleared 510(K)
- K162434NC Gallant PTCA Catheter2Cleared 510(K)
- K163114Sapphire II PRO2Cleared 510(K)
- K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete2Cleared 510(K)
- K163174Emerge PTCA Dilatation Catheter2Cleared 510(K)
- K160985Pantera Pro2Cleared 510(K)
- K162209Sapphire NC Plus2Cleared 510(K)
- K153742Apollo Balloon Dilatation Catheter2Cleared 510(K)
- K160961Mozec NC-Rx PTCA Baloon Dilatation Catheter2Cleared 510(K)
- K160823NC Quantum Apex PTCA Dilatation Catheter2Cleared 510(K)
- K153682Chocolate XD PTCA Balloon Catheter2Cleared 510(K)
- K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm2Cleared 510(K)
- K141933FILAO NC RX PTCA DILATATION CATHETER2Cleared 510(K)
- K150292Chocolate PTCA Balloon Catheter2Cleared 510(K)
- K143480Euphora Rapid Exchange Balloon Dilatation Catheter2Cleared 510(K)
- K143160FOXTROT NC PTCA Balloon Catheter2Cleared 510(K)
- K133852APOLLO BALLOON DILATATION CATHETER2Cleared 510(K)
- K141025ARTIMES BALLOON DILATATION CATHETER2Cleared 510(K)
- K141090NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER2Cleared 510(K)
- K141236NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)2Cleared 510(K)
- K134031THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER2Cleared 510(K)
- K133633CHOCOLATE PTCA BOLLOON CATHETER2Cleared 510(K)
- K131169MOZEC - RX PTCA BALLOON DILATATION CATHETER2Cleared 510(K)
- K123473HOPER PTCA BALLOON CATHETER2Cleared 510(K)
- K131450FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.02Cleared 510(K)
- K130391EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT2Cleared 510(K)
- K123279MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN2Cleared 510(K)
- K123264DK-PTCA BALLOON CATHETER2Cleared 510(K)
- K112735TAMARIN BLUE PTCA RX DILATATION CATHETER2Cleared 510(K)
- K122178FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 12Cleared 510(K)
- K121196EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)2Cleared 510(K)
- K121667NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)2Cleared 510(K)
- K113775FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM2Cleared 510(K)
- K121681GLIDER PTCA BALLOON CATHETER2Cleared 510(K)
- K121222TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER2Cleared 510(K)
- K113220EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)2Cleared 510(K)
- K113464NC TREK OTW CORONARY DILATATION CATHETER2Cleared 510(K)
- K111544GLIDER PTCA BALLOON CATHETER2Cleared 510(K)
- K103808SAPPHIRE NC2Cleared 510(K)
- K111284FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM2Cleared 510(K)
- K103657SAPPHIRE2Cleared 510(K)
- K110133EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER2Cleared 510(K)
- K110617MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER2Cleared 510(K)
- P860019APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK2PMA Approval
- K110134NC TREK RX CORONARY DILATATION CATHETER2Cleared 510(K)
- K103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER2Cleared 510(K)
- P950020FLEXTOME CUTTING BALLOON2PMA Approval
- K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER2Cleared 510(K)
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- K103095SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON2Cleared 510(K)
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P810046CORONARY DILATATION CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P860019APEX PTCA & NC QUANTUM APEX PTCA CATHETERS2PMA Approval
- P860019MAVERICK2 MONORAIL PTCA DILATATION CATHETER2PMA Approval
- P860019PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX)2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P860019BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P860019MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P810046VOYAGER NC CORONARY DILATATION CATHETER2PMA Approval
- P860019APEX PTCA DILATATION CATHETER2PMA Approval
- P810046VOYAGER NC CORONARY DILATATION CATHETER2PMA Approval
- P860019QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS2PMA Approval
- P860019MAVERICK 2 MONORAIL PTCA CATHETER2PMA Approval
- P790017SPRINTER LEGEND RX BALLOON DILATATION CATHETER2PMA Approval
- P860019NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS2PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOON2PMA Approval
- P860019MAVERICK XL PTCA DILATATION CATHETER2PMA Approval
- P950020CORONARY FLEXTONE CUTTING BALLOON2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P950020FLEXTOME CUTTING BALLOON2PMA Approval
- P860019MAVERICK2 PTCA CATHETER/APEX PTCA CATHETER2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P950020FLEXTOME CUTTING BALLOON DILATATIONS DEVICE2PMA Approval
- P860019MAVERICK OVER-THE WIRE PTCA CATHETER2PMA Approval
- P860019APEX PTCA DILATION CATHETERS2PMA Approval
- P880003PTCA DILATATION & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P950020FLEXTOME CUTTING BALLOON2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P880003DURASTAR/FIRESTAR RX PTCA DILATATION CATHETERS2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P860019APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P880003FIRE STAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P860019QUANTUM MAVERICK PTCA CATHETER/MAVERICK OTW PTCA CATHETER2PMA Approval
- P950020FLEXTOME CUTTING BALLOON OTW PTCA CATHETER2PMA Approval
- P860019APEX PTCA BALLOON DILITATION CATHETER2PMA Approval
- P860019MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW2PMA Approval
- P860019APEX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P910031NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P880003FIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P880003DURA STAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P860019APEX PTCA BALLOON DILATION CATHETER2PMA Approval
- P860019APEX MONORAIL & OVER-THE-WIRE PTCA CATHETERS2PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOON DEVICE2PMA Approval
- P860019MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW2PMA Approval
- P860019QUANTUM MAVERICK PTCA /MAVERICK2 PTCA CATHETERS2PMA Approval
- P790017NC SPRINTER RAPID EXCHANGE BALLOON DILATATION CATHETER2PMA Approval
- P860019MAVERICK OTW/MAVERICK 2 MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P950020FLEXTOME CORONARY CUTTING BALLOON2PMA Approval
- P790017GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETERS2PMA Approval
- P790017GRUNTZIG DILACA BALLOON DILATATION CATHETERS2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P860019APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P790017SPRINTER LEGEND RX BALLOON DILATATION CATHETER2PMA Approval
- P790017NC SPRINTER RX BALLOON DILATATION CATHETER2PMA Approval
- P860019QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS2PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOON DEVICE2PMA Approval
- P880003DURA STAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P860019MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER2PMA Approval
- P790017GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETERS2PMA Approval
- P790017NC STORMER BALLOON DILATATION CATHETERS2PMA Approval
- P860019BOSTON SCIENTIFIC QUANTUM MAVERICK PTCA DILATATION CATHETERS2PMA Approval
- P860019MAVERICK, MAVERICK2, MAVERICK XL, QUANTUM MAVERICK2PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOON2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW)2PMA Approval
- P860019MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS2PMA Approval
- P860019QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS2PMA Approval
- P880003FIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL (MR), FLEXTOME CUTTING BALOON OTW, CUTTING BALLOON ULTRA2 MR/OTW2PMA Approval
- P860019MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER2PMA Approval
- P020037FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P790017GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER2PMA Approval
- P880003PTCA DILATATION CATHETERS2PMA Approval
- P880003FIRE STAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P790017GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX22PMA Approval
- P790017GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)2PMA Approval
- P790017SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER2PMA Approval
- P880003DURA STAR RX PTCA BALLOON DILATATION CATHETER2PMA Approval
- P790017SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER2PMA Approval
- P790017GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETER2PMA Approval
- P880003CORDIS PCTA DILATATION CATHETERS2PMA Approval
- P910031MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P860019BOSTON SCIENTIFIC MAVERICK 2 MONORAIL PTCA CATHETERS2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P860019MAVERICK MONORAIL PTCA CATHETER SYSTEM2PMA Approval
- P950020CUTTING BALLOON ULTRA2 MONORAIL2PMA Approval
- P950020CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL2PMA Approval
- P860019MAVERICK PTCA CATHETERS2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL2PMA Approval
- P860019MAVERICK PTCA CATHETERS2PMA Approval
- P860019MAVERICK PTCA CATHETERS2PMA Approval
- P860019MAVERICK PTCA CATHETERS2PMA Approval
- P950020FLEXTOME CUTTING BALLOON MONORAIL DEVICE2PMA Approval
- P950020FLEXTOME & CUTTING BALLOON ULTRA2PMA Approval
- P860019MAVERICK FAMILY PTCA BALLOON CATHETERS2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETERS2PMA Approval
- P860019QUANTUM MAVERICK2PMA Approval
- P860019PTCA/ PERFUSION CATHETERS2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P790017MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER2PMA Approval
- P860019PERCUTANEOUS TRANSPLUMINAL CORONARY ANGIOPLASTY CATHETERS MAVERICK2 MONORAIL PTCA CATHETERS AND NC MONORAIL PTCA CATHETE2PMA Approval
- P910031MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)2PMA Approval
- P910031MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)2PMA Approval
- P860019MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P810046RX VOYAGER CORONARY DILATATION CATHETER2PMA Approval
- P880027PTCA CATHETERS2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P790017NC STORMER OTW BALLOON DILATATION CATHETER2PMA Approval
- P790017SPRINTER MX2 BALLOON DILATATION CATHETER2PMA Approval
- P860019MAVERICK 2 MONORAIL AND MAVERICK OTW PTCA CATHETERS2PMA Approval
- P790017NC STORMER MX2/OTW BALLOON DILATATION CATHETER2PMA Approval
- P860019PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS22PMA Approval
- P790017SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)2PMA Approval
- P810046VOYAGER RX CORONARY DILATATION CATHETER2PMA Approval
- P860019MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P860019PTCA/PERFUSION CATHETERS2PMA Approval
- P880027PTCA CATHETERS2PMA Approval
- P860019QUANTUM MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS2PMA Approval
- P860019NC MONORAIL PTC CATHETER, QUANTUM MONORAIL PTCA CATHETER, MAXXUM PTCA CATHETER, VIVA PTCA CATHETER AND ADANTE PTCA CATHR2PMA Approval
- P860019MAVERICK MONORAIL/QUANTUM MAVERICK MONORAIL PTCA CATHETERS2PMA Approval
- P020037FX MINIRAIL RX PTCA CATHETER2PMA Approval
- P910031JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P020037FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P950020CUTTING BALLOON ULTRA 22PMA Approval
- P790017STORMER Z BALLOON DILATATION/NC STORMER Z BALLOON DILATATION CATHETER2PMA Approval
- P950020CUTTING BALLOON ULTRA2PMA Approval
- P860019REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P790017NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER2PMA Approval
- P790017STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY2PMA Approval
- P860019BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER2PMA Approval
- P860019NC BIG RANGER PTCA CATHETER2PMA Approval
- P860019BOSTON SCIENTIFIC ACE/TRAPPER/SURPASS/REMEDY PTCA CATHETERS2PMA Approval
- P860019MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS2PMA Approval
- P860019MAVERICK 2 MONORAIL PTCA CATHETERS2PMA Approval
- P860019NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS2PMA Approval
- P860019MAVERICK OTW/RANGER PTCA CATHETERS2PMA Approval
- P860019MAVERICK XL PTCA CATHETER (MONORAIL)2PMA Approval
- P860019PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM2PMA Approval
- P860019QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS2PMA Approval
- P860019SCIMED NC RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER2PMA Approval
- P790017STORMER ZIPPER MX BALLOON DILATATION CATHETER2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P860019BOSTON SCIENTIFIC/SCIMED PTCA/PERFUSION CATHETERS2PMA Approval
- P860019PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)2PMA Approval
- P880027PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)2PMA Approval
- P860019MAVERICK MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS2PMA Approval
- P790017STORMER OVER THE WIRE BALLOON DILATATION CATHETER2PMA Approval
- P880003RAPTORRAIL PTCA DILATATION CATHETER2PMA Approval
- P810046POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS2PMA Approval
- P860019MAVERICK MONORAIL PTCA CATHETERS2PMA Approval
- P810046POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER2PMA Approval
- P950020CUTTING BALLOON MONORAIL2PMA Approval
- P880003RAPTORAIL PTCA DILATATION CATHETER (RX)2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P790017NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER2PMA Approval
- P860019MAVERICK OVER THE WIRE PTCA CAHTHETER2PMA Approval
- P880003RAPTORAIL PTCA DILATATION CATHETER2PMA Approval
- P880027SCHNEIDER PTCA CATHETERS2PMA Approval
- P860019SCIMED PTCA CATHETERS2PMA Approval
- P810046PERCUTANEOUS CORONARY DILATATION CATHETERS2PMA Approval
- P860019SCIMED PTCA CATHETERS2PMA Approval
- P880027BOSTON SCINTIFIC SCIMED PTCA CATHETER2PMA Approval
- P880027BONNIE & BYPASS SPEEDY PTCA CATHETER2PMA Approval
- P810046CORONARY DILATATION CATHETER2PMA Approval
- P860019NC MAXXUM PTCA CATHETER2PMA Approval
- P790017R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P810046HIGHSAIL CORONARY DILATATION CATHETER2PMA Approval
- P860019NC MONORAIL PTCA CATHETER2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P860019PTCA CATHETER2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P810046OPEN SAIL CORONARY DILATATION CATHETER2PMA Approval
- P860019MAVERICK MONORAIL2PMA Approval
- P860019PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)2PMA Approval
- P880027PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)2PMA Approval
- P810046POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER2PMA Approval
- P810046CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS2PMA Approval
- P860019(R) QUANTUM MONORAIL(TM) PTCA CATHETER2PMA Approval
- P810046RX CHASSIS I CORONARY DILATATION CATHETER2PMA Approval
- P790017D114S OTW BALLOON DILATATION CATHETER2PMA Approval
- P860019MAXXUM AND NC MAXXUM PTCA CATHETER2PMA Approval
- P950020CUTTING BALLOON2PMA Approval
- P810046CROSS SAIL CORONARY DILATATION CATHETER2PMA Approval
- P860019BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE2PMA Approval
- P860019SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER2PMA Approval
- P880003NC NINJA PTCA DILATATION CATHETER2PMA Approval
- P790017R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER2PMA Approval
- P790017D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER2PMA Approval
- P880003NINJA FX PTCA DILATATION CATHETER2PMA Approval
- P860019SCIMED PTCA CATHETERS2PMA Approval
- P860019QUANTUM RANGER, NC RANGER, COYOTE, AND MAXXUM PTCA CATHETERS2PMA Approval
- P810046CROSSSAIL/OPENSAIL CORONARY DILATATION CATHETER2PMA Approval
- P880003RAPTOR PTCA DILATATION CATHETER2PMA Approval
- P860019SCIMED PTCA CATHETER2PMA Approval
- P880027BOSTON SCIENTIFIC SCIMED PTCA CATHETERS2PMA Approval
- P860019PTCA CATHETER2PMA Approval
- P860019ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER2PMA Approval
- P860019MAXXUM PTCA CATHETER2PMA Approval
- P880027TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019PTCA CATHETERS2PMA Approval
- P810046ACS OTW PHOTON CORONARY DILATATION CATHETER2PMA Approval
- P990008COOK MBC PTCA BALLOON DILATATION CATHETER2PMA Approval
- P790017D114S OVER-THE-WIRE BALLOON DILATATION CATHETER2PMA Approval
- P810046ACS OTW PHOTON CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER2PMA Approval
- P810046ACS OTW SOLARIS CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED PTCA CATHETERS2PMA Approval
- P810046ACS RX SOLARIS CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED PTCA CATHETER2PMA Approval
- P860019SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019ADANTE PTCA CATHETER2PMA Approval
- P810046ACS RX GEMINI CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED SINGLE OPERATOR EXCHANGE PTCA CATHETERS2PMA Approval
- P810046ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)2PMA Approval
- P860019SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P790017OVER THE WIRE DILATATION CATHETERS2PMA Approval
- P810046PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER2PMA Approval
- P810046ACS RX GEMINI CORONARY DILATATION CATHETER2PMA Approval
- P910031THE ORACLE MEGASONICS FIVE-64 PTCA CATHER2PMA Approval
- P880003NINJA PTCA DILATION CATHETERS2PMA Approval
- P870036THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER2PMA Approval
- P880003CHARGER PTCA DILATION CATHETERS2PMA Approval
- P810046ACS RX SOLARIS CORONARY DILATATION CATHETER2PMA Approval
- P960014MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C235202PMA Approval
- P860019SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P790017NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE2PMA Approval
- P860019SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P930012LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES2PMA Approval
- P880027BONNIE (TM) PTCA CATHERS2PMA Approval
- P930012LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE2PMA Approval
- P860019SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P880003CHARGER PTCA DILATATION CATHETERS2PMA Approval
- P860019SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P880003CORDIS TITAN & TITAL XL DILATION CATHETERS2PMA Approval
- P810046ACS RX ESPRIT CORONARY DILATION CATHETER2PMA Approval
- P860019SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046ACS RX ROCKET CORONARY DILATION CATHETER2PMA Approval
- P860019SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046ACS RX ESPRIT CORONARY DILATION CATHETER2PMA Approval
- P880027BONNIE TM SLIDING RAIL PTCA CATHETERS2PMA Approval
- P930012CHAMPION WRAP PTCA CATHETER2PMA Approval
- P810046ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC2PMA Approval
- P880003CHARGER PTCA DILATATION CATHETERS2PMA Approval
- P970052GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER2PMA Approval
- P790017USCI APOLLO RELY ADDITIONAL SIZES2PMA Approval
- P810046ACS RX ROCKET ACS AVENGER CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P910031ORACLE MEGASONICS FIVE-64 PTCA CATHETER2PMA Approval
- P860019SCIMED REBEL PTCA CATHETER2PMA Approval
- P970052LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).2PMA Approval
- P860019SCIMED REBEL PTCA CATHETER2PMA Approval
- P790017USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE2PMA Approval
- P810046ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER2PMA Approval
- P930012CHAMPION WRAP PTCA CATHETER2PMA Approval
- P970052FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS2PMA Approval
- P790017TELESCOPE PTCA BALLOON CATHETER2PMA Approval
- P930012CHAMPION WRAP PTCA CATHETER2PMA Approval
- P810046ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS2PMA Approval
- P880027BONNIE TM SLIDING RAIL PTCA CATHETERS2PMA Approval
- P860019SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P790017USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON2PMA Approval
- P860019SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P790017USCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE2PMA Approval
- P810046ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS2PMA Approval
- P880027BONNIE SLIDING RAIL PTCA CATHETERS2PMA Approval
- P840040SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER2PMA Approval
- P880003TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS2PMA Approval
- P910031GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER2PMA Approval
- P880027TAKUMI OVER THE WIRE PTCA CATHETERS2PMA Approval
- P810046ACS RX ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS2PMA Approval
- P860019SCIMED BANDIT AND RANGER PTCA CATHETERS2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P880027BONNIE (TM) PTCA CATHERS2PMA Approval
- P880027BONNIE (TM) PTCA CATHERS2PMA Approval
- P880027BONNIE (TM) PTCA CATHERS2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046ACS RX ESPRIT2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P790017PROCROSS RELY SP PTCA CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046ACS RX COMET CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P870036MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P880003TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS2PMA Approval
- P860019SCIMED(R) NC REBEL (TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P870036MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL2PMA Approval
- P880003CHARGER PTCA DILATATION CATHETERS2PMA Approval
- P810046ACS RX LIFESTREAM2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED NC BIB RANGER PTCA CATHETER2PMA Approval
- P810046ACS RX LIFESTREAM2PMA Approval
- P910031ORACLE MEGASONICS FIVE-64 PTCA CATHETER2PMA Approval
- P810046ACS TX2000 VP CORONARY DILITATION CATHETER2PMA Approval
- P890001LEOCOR SABLE(TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P890001LEOCOR PICO-ST2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P930012THE WRAP(PTCA) CATHETER2PMA Approval
- P810046ACS CORONARY DILATATION CATHETERS (INDICATION)2PMA Approval
- P810046ACS RX COMET CORONARY DILATION CATHETER2PMA Approval
- P880003THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS2PMA Approval
- P880003PTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA2PMA Approval
- P860019SCIMED(R)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046TX-20002PMA Approval
- P810046ELIPSE 14,000.014 CORONARY DILATATION CATHETER2PMA Approval
- P910031FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS2PMA Approval
- P860019SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER2PMA Approval
- P810046ACS TX2000 VP CORONARY DILITATION CATHETER2PMA Approval
- P870036MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS2PMA Approval
- P790017USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL2PMA Approval
- P910031ARC(TM) BALLOON CORONARY DILATATION CATHETERS2PMA Approval
- P880027GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS2PMA Approval
- P880027ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS2PMA Approval
- P880003TITAN MEGA AND TITAN MEGA XL2PMA Approval
- P890048USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS2PMA Approval
- P880027SCHNEIDER CHUBBY(TM) PTCA CATHETERS2PMA Approval
- P810046ACX RX COMET VP CORONARY DILATATION CATHETER2PMA Approval
- P930012PAS CHAMPION HP PTCA CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P880003THOR PTCA DILATION CATHETERS2PMA Approval
- P890001LEOCOR SABLE(TM) PTCA CATHETER2PMA Approval
- P810046ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)2PMA Approval
- P910031FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS2PMA Approval
- P890048USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS2PMA Approval
- P880003VALOR AND VALOR XL PTCA DILATATION CATHETERS2PMA Approval
- P930012PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS2PMA Approval
- P810046ACS RX COMET(TM) CORONARY DILATION CATHETER2PMA Approval
- P880003VALOR AND VALOR XL PTCA DILATATION CATHETERS2PMA Approval
- P810046ACS RX STREAK & ACS FLOW TRACK 402PMA Approval
- P870036MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS2PMA Approval
- P810046ACS TX2000TM CORONARY DILATION CATHETER2PMA Approval
- P860019SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P870036MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS2PMA Approval
- P890001LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT2PMA Approval
- P910031FACT(TM) BALLOON CORONARY DILATION CATHETER2PMA Approval
- P810046ACS(R) PINKERTON .018(TM) CORONARY DILATION CATHETER2PMA Approval
- P880027CHUBBY(TM) PTCA CATHETERS2PMA Approval
- P790017USCI(R) PROCROSS(TM) OVER-THE-WIRE BALLOON DILATION WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING2PMA Approval
- P870036MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS2PMA Approval
- P860019SCIMED RANGER PTCA CATHETERS2PMA Approval
- P860019SCIMED NC BANDIT PTCA CATHETER2PMA Approval
- P910031FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS2PMA Approval
- P810046SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH2PMA Approval
- P880003THOR PTCA DILATION CATHETERS2PMA Approval
- P860019SCIMED(R) SURPASS(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY2PMA Approval
- P880027GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS2PMA Approval
- P880003CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY DILATATION CATHETERS2PMA Approval
- P890001LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)2PMA Approval
- P890001LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP2PMA Approval
- P880027ASUKA AND ASUKA LONGY OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS2PMA Approval
- P860019SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)2PMA Approval
- P890001LEOCOR PICO RUNNER(TM) PTCA CATHETER2PMA Approval
- P880003CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS2PMA Approval
- P910031CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER2PMA Approval
- P930012PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER2PMA Approval
- P790017USCI GRUNTZIG DILICA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI PROCROSS ELITE OVER THE WIRE W/PRO/PEL COATING2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETER, TITAN AND TITAN XL PTCA DILATATION CATHETERS2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETERS AND CORDIS THOR PTCA DILATATION CATHETERS2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETER AND CORDIS VALOR AND VALOR XL PTCA DILATATION CATHETERS2PMA Approval
- P790017USCI(R)GRUNTZIG DILACA CATHETER2PMA Approval
- P930012EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE2PMA Approval
- P880003CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS2PMA Approval
- P870036VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR2PMA Approval
- P930012PAS LACROSSE TM PTCA CATHETER2PMA Approval
- P880003TITAN AND TITAN XL PTCA DILATATION CATHETERS2PMA Approval
- P910031ORACLE(TM) CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P860019SCIMED(R) 10MM & 20MM NC BANDIT(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER2PMA Approval
- P810046ACS CORONARY DILITATION CATHETER2PMA Approval
- P790017USCI(R)BALLOON DILATATION CATH. W/PETELITE(TM)2PMA Approval
- P860019SCIMED WAVE2PMA Approval
- P810046ACS CONCORFE(TM) CORONARY DILATION BALLOON CATHETER2PMA Approval
- P910031CATHSCANNER ORACLE MICRO PTCA CATHETER FACT BALLOON CORONARY DILATION CATHETER2PMA Approval
- P790017USCI GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI XPRT WITH PRO/PEL COATING BALLOON DILATATION2PMA Approval
- P910031CATHSCANNER ORACLE MICRO PTCA CATHETER2PMA Approval
- P810046SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS2PMA Approval
- P870036VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 402PMA Approval
- P910031CATHSCANNER ORACLE MICRO PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P880003CORDIA PTCA DILATION CATHETERS2PMA Approval
- P810046ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P850021AMERICAN EDWARDS LABORATORIES HYBRID PTCA CATHETER, PURSUIT 14 PTCA CATHETER2PMA Approval
- P880027SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER2PMA Approval
- P860019SCIMED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS AND TRAPPER EXCHANGE DEVICE2PMA Approval
- P810046ACS SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P860019SCIMED NC EXPRESS PLUS PTCA CATHETER2PMA Approval
- P860019SCIMED NC EXPRESS PLUS HD PTCA CATHETER2PMA Approval
- P860019SCIMED LEAP EXPRESS PLUS2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P840040SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER2PMA Approval
- P840040SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER2PMA Approval
- P910031ORACLE(TM) CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P860019NC BANDIT PTCA CATHETER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P840040SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER2PMA Approval
- P860019LEAP EXPRESS PLUSS2PMA Approval
- P860019LEAP EXPRESS PLUSS2PMA Approval
- P860019LEAP EXPRESS PLUSS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880003CORDIS PTCA DILITATION CARTHETERS2PMA Approval
- P880027SCHNEIDER FREEHAND(R) PTCA CATHETERS2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P890048USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS2PMA Approval
- P810046ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P790017USCI(R) GRUNTZIG DILACA CATHETER2PMA Approval
- P810046ACS CORONARY DILITATION CATHETER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880027SCHNEIDER SHORTGOOSE NONCOMPLIANT CATHETER2PMA Approval
- P910031ORACLE(TM) CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P890048USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS2PMA Approval
- P860019SCIMED POC BANDIT PTCA CATHETER2PMA Approval
- P880027SCHNEIDER MICROSOFT(TM) PTCA CATHETERS2PMA Approval
- P860019SCIMED POC BANDIT PTCA CATHETER2PMA Approval
- P870036MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH.2PMA Approval
- P860019SCIMED(R) LEAP TRIO(TM) PTCA CATHETER2PMA Approval
- P870036MEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P890001LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT2PMA Approval
- P870036MEDTRONIC(R) EVERGREEN 40 CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P880027SCHNEIDER FREEHAND(R) PTCA CATHETERS2PMA Approval
- P880027SCHNEIDER FREEHAND(TM) & MC RAIL PTCA CATHETERS2PMA Approval
- P810046ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P880027SCHNEIDER FREEFLIGHT(TM) PTCA CATHETERS2PMA Approval
- P810046ACS CORONARY DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P840040SYNERGY II CONVERTIBLE RAPID EXCHANGE CATHETER2PMA Approval
- P870036MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH.2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P840040CORONARY BALLOON DILITATION CATHETERS PTCA2PMA Approval
- P880003CORDIS TRASKAR 18 PTCA DILITATION CATHETERS2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P860019SCIMED(R) DYNA-MITE(T)PTCA CATHETER2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P860019SCIMED(R) NC COBRA 18 PTCA CATHETER2PMA Approval
- P810046ACS RX FLOWTRACK LONG(TM) CORONARY DILATATION CATH2PMA Approval
- P870036MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH2PMA Approval
- P840040MIGHTY(TM) CORONARY BALLOON DILATATION CATHETERS2PMA Approval
- P880003CORDIS BASIC 18 PTCA DILATATION CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) TRIO(TM) 14 PTCA CATHETER2PMA Approval
- P8400403.4F SYNERGY(TM) II LONG BALL. DILATATION CATHETER2PMA Approval
- P8400402.9F-TO-3.4F ALLY(TM) PTCA CATHETER2PMA Approval
- P880003CORDIS EUROPASS PTCA DILATATION CATHETER2PMA Approval
- P910031ORACLE(TM) CORONARY BALLOON DILATATION CATHETER2PMA Approval
- P880003CORDIS PREDATOR PTCA DILATATION CATHETER2PMA Approval
- P880003CORDIS SLEEK DILATATION CATHETERS2PMA Approval
- P940009PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH2PMA Approval
- P880003CORDIS WORLDPASS PTCA DILITATION CATHETER2PMA Approval
- P840040MIGHTY(TM) PTCA BALLOON DILITATION CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) INDY(TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P870036MEDTRONIC(R) EVERGREEN(TM) COR.BALL.DIL. CATH.2PMA Approval
- P870036MEDTRONIC(R) PANTHER (TM) 40 COR..BALL. DIL. CATH.2PMA Approval
- P860019SCIMED(R) NC COBRA(TM) 14 PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P880003QRAKSTAR 14 PTCA CATHETERS2PMA Approval
- P880003TRAKSTAR 18 PTCA CATHETERS2PMA Approval
- P810046ACS RX ELIPSE(TM) .014 CORNARY DILITATION CATH.2PMA Approval
- P890001LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT2PMA Approval
- P890001LEOCOR PICO RUNNER CATHETER2PMA Approval
- P840040SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P870036MEDTRONIC(R)SPIRIT(TM)30 & 40 COR.BALL. DIL. CATH.2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P810046ACS RX FLOWTRACK(TM) LONG COR. DILITATION CATH.2PMA Approval
- P840040POBA(TM) AND SAAVY(TM) PTCA CATHETERS2PMA Approval
- P810046ACS CORONARY DILITATION CATHETERS2PMA Approval
- P810046ACS RX PRIMAFLOW (TM) CORO.DILATION CATHETER2PMA Approval
- P810046ACS EDGE (TM)DILATATION CATHETERS2PMA Approval
- P880027SCHNEIDER MYSTIC(TM) 20,30,40 MC PTCA CATHETERS2PMA Approval
- P860019SCIMED(R) LONG CRUISE (TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P880027SCHNEIDER MC RAIL(TM) 20,30,40 SLIDING RAIL PTCA2PMA Approval
- P860019SCIMED(R) (PTCA) CATHETER2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880003CORDIS SLEEK PLUS PTCA DILITATION CATHETERS2PMA Approval
- P860019SCIMED(R) NC CRUISE(TM) PTCA CATHETER2PMA Approval
- P810046ACS RX PERFUSION(TM) CORONARY DILITATION CATHETER2PMA Approval
- P860019SCIMED(R) LONG CRUISE (TM) PTCA CATHETER2PMA Approval
- P840040SYNERGY(TM)II CONVERTIBLE RAPID EXCHANGE PTCA CATH2PMA Approval
- P890001LEOCOR,INC. CORFLO(TM) MODEL 7.5S PTCA CATHETERS2PMA Approval
- P850021HYBRID (TM)&QUICK(TM) 14 PTCA CATHETER2PMA Approval
- P850021OEACH(TM).14,& READY(TM).14,PTCA CATHETER2PMA Approval
- P810046ACS CORONARY DILATATION CATHETERS2PMA Approval
- P860019SCIMED(R) RALLY TURBO (TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) RALLY TURBO (TM) PTCA CATHETER2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETERS2PMA Approval
- P880003CORDIS OLYMPIX,SLEUTH,& PREDATOR PTCA CATHETERS2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETERS2PMA Approval
- P790017USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL2PMA Approval
- P790017USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P880027SCHNEIDER FREEHAND(TM) MODELS FH20-20,25,30,35,402PMA Approval
- P810046RX ELIPSE(TM) .014 CORONARY DILITATION CATHETER2PMA Approval
- P860019SCIMED(R) SC COBRA(TM) 14 PTCA CATHETER2PMA Approval
- P870036MEDTRONIC(R)PANTHER(TM) CORONARY BALL. DILI. CATH.2PMA Approval
- P870036MEDTRONIC(R) RAIDER(TM) CORONARY BALL. DILI. CATH.2PMA Approval
- P850021HYBRID (PTCA) CATHETER2PMA Approval
- P840040PTCA BALLOON DILITATION CATHETERS2PMA Approval
- P810046ACS RX ELIPSE(TM) .014 CORONARY DILITATION CATH.2PMA Approval
- P810046ACS SPACTRUM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P810046CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE2PMA Approval
- P880027SCHNEIDER FREEHAND (TM) PTCA CATHETER2PMA Approval
- P880003CORDIS OLYMPIX,SLEEK, & PREDATOR PTCA CATHETERS2PMA Approval
- P810046ACS RX ELIPSE & ELIPSE II CORO.DIL. CATHETERS2PMA Approval
- P860019SCIMED(R) ACE(TM) 1CM TIP PTCA CATHETER2PMA Approval
- P860019SCIMED(R) LONG RALLY (TM) PTCA CATHETER2PMA Approval
- P810046ACS CORONARY DILATATION CATHETERS2PMA Approval
- P870036MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER2PMA Approval
- P810046ACS RX FLOWTRACK (TM) 40 CORO. DILITATION CATH.2PMA Approval
- P880003CORDIS PREDATOR PTCA DILITATION CATHETER2PMA Approval
- P840040SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH.2PMA Approval
- P880027SCHNEIDER PTCA CATHETER2PMA Approval
- P870036MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH2PMA Approval
- P870036MEDTRONIC(R) SPIRIT(TM) CORONARY BALL. DILAT. CATH2PMA Approval
- P810046ACS CORONARY DILATATION CATHETERS2PMA Approval
- P880003CORDIS PTCA DILATATION CATHETERS2PMA Approval
- P860019SCIMED(R) PIVOT (TM) PTCA CATHETER2PMA Approval
- P880003CORDIS SLEEK PTCA DILATATION CATHETERS2PMA Approval
- P810046STACK PERFUSION IV CORONARY DILATION CATHETER2PMA Approval
- P810046ACS EDGE(TM) CORONARY DILITATION CATHETER2PMA Approval
- P880003CORDIS PREDATOR PTCA DILITATION CATHETER2PMA Approval
- P810046CHANGES TO PINKERTON & OMEGA CORO.DIL. CATHETERS2PMA Approval
- P860019SCIMED QUANTUM(TM) PTCA CATHETER2PMA Approval
- P840040SLIDER (TM)3.4F LONG BALLOON DILATATION PTCA CATH2PMA Approval
- P880003SLEEK PTCA DILATATION CATHETERS W/3 & 4CM BALLONS2PMA Approval
- P810046CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS2PMA Approval
- P860019SCIMED(R) NC RALLY(TM) PTCA CATHETER2PMA Approval
- P850021REACH(TM).14 PTCA CATHETER2PMA Approval
- P880003OLYMPIX & SLEUTH XT PTCA CATHETERS W/4CM BALLOONS2PMA Approval
- P880003OLYMPIX & SLEUTH XT PTCA CATHETERS W/3CM BALLOONS2PMA Approval
- P880003SLEEK PTCA DILATION CATHETER2PMA Approval
- P890032CORDIS ORION II STEERABLE BALLOON CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER NC COBRA 142PMA Approval
- P860019SCIMED(R) PTCA CATHETER SHADOW(TM)P-142PMA Approval
- P860019SCIMED(R) PTCA CATHETER NC COBRA 142PMA Approval
- P790017USCI(R) SPRINT(TM) BALL. DIL. CATH. WITH BANKA(TM)2PMA Approval
- P790017USCI(R) XPRT(TM) BALL. DIL. CATH. W/PRO/PEL(TM)2PMA Approval
- P790017USCI(R)SOLITAIRE(TM) BALL.DIL.CATH.W/PRO/PEL(TM)2PMA Approval
- P810046ACS RX PERFUSION(TM) DILATATION CATHETER2PMA Approval
- P870036MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER2PMA Approval
- P860019SCIMED(R) TRAPPER (TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) RALLY(TM) PTCA CATHETER2PMA Approval
- P890001LEOCOR CORFLO(TM) MODEL 7.1PT (COATED)2PMA Approval
- P890001LEOCOR PICOCATH(TM) MODEL PICO-ST2PMA Approval
- P810046ACS TEN (TM) CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED(R) ACE,LONG,EXPR. HYPO-SEAL(TM) ACCESSORY2PMA Approval
- P870036MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER2PMA Approval
- P860019SCIMED(R) ACE,LONG,GRAFT PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P840040SLIDER(TM)/SUPER THIN CORONARY BALLOON DILATION C2PMA Approval
- P880027SCHNEIDER MYSTIC (TM) PTCA CATHETER2PMA Approval
- P810046ACS PRISM(TM) & PINKERTON .018(TM)COR.DIL. CATH.2PMA Approval
- P810046ACS STACK 40-S(TM) CORONARY DILATATION CATH.2PMA Approval
- P880027SCHNEIDER PTCA CATHETER2PMA Approval
- P870036MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P810046ACS RX STREAK(TM) .010 CORONARY DILATATION CATH.2PMA Approval
- P810046ACS RX STREAK (TM) & FLOWTRACK DILATION CATHETERS2PMA Approval
- P860019SCIMED(R) ACE,LONGACE (TM)PTCA CATHETER CHANGES2PMA Approval
- P860019SCIMED(R) GRAFT ACE(TM) PTCA CATHETER2PMA Approval
- P860019SCIMED(R) PTCA CATHETER KING COBRA (TM)2PMA Approval
- P860019SCIMED LONG KING COBRA 30 & 40 PTCA CATHETERS2PMA Approval
- P850021LONG REACH(TM) 30MM PTCA CATHETER2PMA Approval
- P860019SCIMED ACE(TM) & LONG ACE(TM) PTCA CATHETERS2PMA Approval
- P850021SLINKY(TM),EDGE(TM),QUICK(TM),PTCA CATHETER2PMA Approval
- P840040SYNERGY(TM)CONV. RAPID EXCHANGE PTCA CATHETER2PMA Approval
- P840040SLIDER(TM) STRETCH CORONARY BALL. DILITATION CATH.2PMA Approval
- P880027SCHNEIDER XLP & PICCOLINO PTCA CATHETER CHANGES2PMA Approval
- P840040NITECH(TM) CORONARY BALLOON DILITATION CATHETER2PMA Approval
- P870036MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE2PMA Approval
- P870036MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE2PMA Approval
- P880003HELIX UPGRADE PTCA DILATATION CATHETERS2PMA Approval
- P840040SLIDER(TM)/2.0 MM BALLOON DILATION CATHETER2PMA Approval
- P890032CORDIS 3.5MM SOFT-WIRE ORION STEERABLE PTCA CATH.2PMA Approval
- P810046ACS RX PERFUSION(TM) CORONARY DILATATION CATH.2PMA Approval
- P880027SCHNEIDER MONGOOSE(TM) PTCA CATHETER2PMA Approval
- P810046ACS(R) RX FLOWTRACK(TM) 40 CORONARY DILITATIN CATH2PMA Approval
- P790017USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT2PMA Approval
- P810046ACS RX STREAK(TM) .014 CORONARY DILATATION CATH.2PMA Approval
- P860019STRONG SHADOW(TM) CATHETER2PMA Approval
- P870036MEDTRONIC(R) CORONARY BALLOON DILITATION CATHETERS2PMA Approval
- P840040SLIDER(TM) 018 CORONARY BALLOON SLEEVE MODIFI.2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880003HELIX PTCA DILATION CATHETERS AND Y- CONNECTORS2PMA Approval
- P840040SLIDER(TM) 018 CORONARY BALLOON DILITATION CATH.2PMA Approval
- P810046ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.02PMA Approval
- P810046ACS STACK 40-S(TM) CORONARY DILATATION CATHETER2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA CATH. W/GLISSADE HYDRO2PMA Approval
- P870036MEDTRONIC(R) 18K(TM) OVER-THE-WIRE CORO.BALL.CATH.2PMA Approval
- P880003HELIX PTCA DILATATION CATHETER2PMA Approval
- P840040NITECH TM 018 PTCA CATHETER2PMA Approval
- P810046ACS CORONARY DILATATION CATHETERS2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P810046CHANGES TO ACS(R) RX STREAK(TM).014 & .010 CATH.2PMA Approval
- P810046ACS (R) RX STREAK (TM)CORONARY DILATION CATHETER2PMA Approval
- P850021REACH(TM).14 PTCA CATH.1.5MM & 4.0MM BALL. SIZES2PMA Approval
- P810046ACS RX ALPHA CORONARY DILATION CATHETERS2PMA Approval
- P850021AMERICAN EDWARDS LABS HYBRID PTCA CATHETER2PMA Approval
- P840040PTCA CATHETER EXTENSION OF SILICONE COATING2PMA Approval
- P860019SCIMED COBRA 10(TM) CATHETER2PMA Approval
- P850021SLINKY(TM) PTCA CATHETER2PMA Approval
- P860019SCIMED ACE(TM)&LONG ACE(TM)PTCA CATHETERS2PMA Approval
- P890032CORDIS 3.5 MM SOFT-WIRE ORION STEERABLE PTCA BALL.2PMA Approval
- P870036MEDTRONIC(R) 14K OVER THE WIRE CORONARY BALL.CATH.2PMA Approval
- P810046ACS XT 600 CORONARY DILITATION CATHETER2PMA Approval
- P810046ACS SLALOM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P810046ACS SLALOM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P880027SCHNEIDER MAGNARAIL (PTCA) CATHETER2PMA Approval
- P880027SCHNEIDER XLP(TM)30 PTCA CATHETER2PMA Approval
- P880027SCHNEIDER MICROSOFTRAC(R) PTCA CATHETER2PMA Approval
- P880027SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH.2PMA Approval
- P810046ACS CORONARY BALLOON DILITATION CATHETER2PMA Approval
- P810046HARTZLER ACX II(R) CORONARY DILATATION CATHETER2PMA Approval
- P860019SCIMED PTCA CATHETER (TRAPPER(TM))2PMA Approval
- P860019THE SHADOW(TM) P-14 PTCA CATHETER2PMA Approval
- P810046ACS (R) RX STREAK (TM)CORONARY DILATION CATHETER2PMA Approval
- P810046ACS SLALOM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P850021REACH(TM).14 PTCA CATHETER2PMA Approval
- P810046ACS, OMEGA DILITATION CATHETER2PMA Approval
- P860019SCIMED COBRA 14 CATHETER2PMA Approval
- P790017USCI(R) SPRINT(TM) BALL. DIL. CATH. W/PRO/PEL COAT2PMA Approval
- P790017USCI(R) FORCE(R) BALL. DIL. CATH. W/PRO/PEL COAT.2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P860019PHANTOM(TM) CATHETER2PMA Approval
- P810046CORONARY DILATION CATHETERS2PMA Approval
- P860019SCIMED ACE(TM) & EXPRESS(TM) PTCA CATHETERS2PMA Approval
- P860019SCIMED TRAPPER(TM) EXCHANGE DEVICE2PMA Approval
- P890001LEOCOR PICOCATH(TM) MODEL PICO-ST2PMA Approval
- P870036MEDTRONIC(R) 18K(TM) OVER THE WIRE BALL. CATHETER2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880003HELIX PTCA DILATATION CATHETER2PMA Approval
- P850021AMERICAN EDWARDS LABS HYBRID PTCA CATHETER2PMA Approval
- P810046ACS RX ALPHA CORONARY DILATION CATHETERS2PMA Approval
- P860019ACE(TM) AND LONG ACE(TM) MODELS2PMA Approval
- P860019SCIMED(R) PTCA CATHETER2PMA Approval
- P810046ACS RX(R) ALPHA .O14 CORONARY DILITATION CATHETER2PMA Approval
- P810046ACS RX ALPHA CORONARY DILATION CATHETERS2PMA Approval
- P880027SCHNEIDER XLP(TM) PTCA CATHETER2PMA Approval
- P880003HELIX PTCA DILATATION CATHETER2PMA Approval
- P810046SELF-VENT TO ACS CORONARY DILATATION CATHETER2PMA Approval
- P890032CORDIS ORION STEERABLE PTCA BALLOON CATHETER2PMA Approval
- P880055MICROSS-SL(TM) PTCA DILATATION CATHETER2PMA Approval
- P840040HEART TRAK PTCA CATHETER2PMA Approval
- P840040HEART TRAK PTCA CATHETER2PMA Approval
- P810046ACS RX ALPHA(TM).010 CORONARY DILITATION CATHETER2PMA Approval
- P810046ACS SPECTRUM(TM) CORONARY DILATATION CATHETER2PMA Approval
- P810046SELF-VENT TO ACS CORONARY DILATATION CATHETER2PMA Approval
- P880027SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH.2PMA Approval
- P890001LEOCOR CORFLO(TM) MODEL 7.5PT PTCA CATHETER2PMA Approval
- P840040HEART TRAK PTCA CATHETER2PMA Approval
- P810046ACS RX ALPHA(TM) .018 CORONARY DILATATION CATHETER2PMA Approval
- P880027SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER2PMA Approval
- P880027SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER2PMA Approval
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- P860019SCIMED PTCA DILATATION CATHETER2PMA Approval
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- P860019SCIMED PTCA DILATATION CATHETER2PMA Approval
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- P810046SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE2PMA Approval
- P810046SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE2PMA Approval
- P810046SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE2PMA Approval
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- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
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- Subpart F—Therapeutic DevicesCFR Sub-Part
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Sapphire II PRO Balloon Dilatation Catheter
- Page Type
- Cleared 510(K)
- 510(k) Number
- K180921
- 510(k) Type
- Traditional
- Applicant
- OrbusNeich Medical Trading Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/28/2018
- Days to Decision
- 80 days
- Submission Type
- Summary