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
- K240078Fogarty Thru-Lumen Embolectomy Catheter2Cleared 510(K)
- K241330Fogarty Fortis Arterial Embolectomy Catheter2Cleared 510(K)
- K233819Fogarty Venous Thrombectomy Catheters2Cleared 510(K)
- K233820Fogarty Arterial Embolectomy Catheter with Gate Valve2Cleared 510(K)
- K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2Cleared 510(K)
- K213771Merlin Aspiration System2Cleared 510(K)
- K202049Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter2Cleared 510(K)
- K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe2Cleared 510(K)
- K163031Bunegin-Albin Air Aspiration Set2Cleared 510(K)
- K163353Needle's Eye Snare Retrieval Set - 54cm2Cleared 510(K)
- K152335Export Advance Aspiration Catheter2Cleared 510(K)
- K100842PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM2Cleared 510(K)
- K100840EMBO PLUS EMBOLECTOMY CATHETER2Cleared 510(K)
- K081573MEDTRONIC EXPORT AP CATHETER2Cleared 510(K)
- K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 23022Cleared 510(K)
- K020634MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER2Cleared 510(K)
- K011783MULTI-SNARE SET2Cleared 510(K)
- K002627ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER2Cleared 510(K)
- K992933LEMAITRE IRRIGATION CATHETER2Cleared 510(K)
- K992934LEMAITRE VENOUS THROMBECTOMY CATHETER2Cleared 510(K)
- K992940LEMAITRE BALLOON CATHETER WITH IRRIGATION2Cleared 510(K)
- K992368LEMAITRE EMBOLECTOMY CATHETER2Cleared 510(K)
- K973477BIOSENSORS EMBOLECTOMY CATHETER2Cleared 510(K)
- K982141ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-560252Cleared 510(K)
- K971314DCAT EMBOLECTOMY CATHETER SYSTEM2Cleared 510(K)
- K972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETER2Cleared 510(K)
- K973465LATIS GRAFT CLEANING CATHETER2Cleared 510(K)
- K974335EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.2Cleared 510(K)
- K972572SINGLE LUMEN EMBOLECTOMY CATHETER2Cleared 510(K)
- K972623LMI IRRIGATION CATHETER (IGR)2Cleared 510(K)
- K970657LMI THROMBECTOMY CATHETER2Cleared 510(K)
- K970762DUAL LUMEN EMBOLECTOMY CATHETER2Cleared 510(K)
- K961883VERSA-CATH ARTERIAL CATHETER2Cleared 510(K)
- K961992NEEDLE'S EYE SNARE2Cleared 510(K)
- K961716VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE2Cleared 510(K)
- K954760LMI ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K955125LMI OCCLUSION CATHETER2Cleared 510(K)
- K950586AVD INTIMAX THROMBECTOMY CATHETER2Cleared 510(K)
- K935405ARTERIAL EMBOLECTOMY2Cleared 510(K)
- K920823WELTER SNARE RETRIEVER2Cleared 510(K)
- K920871J-LLOYD ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K914880DUAL BALLOON EMBOLECTOMY CATHETER2Cleared 510(K)
- K910372INTIMAX THROMBECTOMY CATHETER2Cleared 510(K)
- K905139CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K902327EMBOLECTOMY CATHETER2Cleared 510(K)
- K901502AMPLATZ GOOSE-NECK SNARE2Cleared 510(K)
- K901627ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K900311ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETER2Cleared 510(K)
- K8971843F AND 4F IRRIGATION EMBOLECTOMY CATHETERS2Cleared 510(K)
- K883852CATHETER, CARDIOVASCULAR, BALLOON TYPE2Cleared 510(K)
- K894681REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K891021TRI-LUMEN INTRA VASCULAR BALLOON CATHETER2Cleared 510(K)
- K893680SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.2Cleared 510(K)
- K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER2Cleared 510(K)
- K881455EMBOLECTOMY CATHETER(MODIFIED)2Cleared 510(K)
- K872485CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)2Cleared 510(K)
- K864330SHEAR FORCE GAUGE2Cleared 510(K)
- K864062PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)2Cleared 510(K)
- K864007EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER2Cleared 510(K)
- K853625NOVA ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K850015POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K840198ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- K832044SHILEY MULTIPRO CATHETER2Cleared 510(K)
- K832023EMBOLECTOMY CATHETER2Cleared 510(K)
- K820646ATRAC TM MULTIPURPOSE BALLOON CATHETER2Cleared 510(K)
- K812640URE SIL EMBOLECTOMY/THROMBECTOMY CATH2Cleared 510(K)
- K801650DESERET EMBOLECTOMY/THROMBECTOMY CATH.2Cleared 510(K)
- K790838ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)2Cleared 510(K)
- K780762EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE2Cleared 510(K)
- K780244CATHETERS, ARTERIAL EMBOLECTOMY2Cleared 510(K)
- K770714CATHETER, ARTERIAL EMBOLECTOMY2Cleared 510(K)
- K770569CATHETER, EMBOLECTOMY, UMI2Cleared 510(K)
- K761031ELECATH ARTERIAL EMBOLECTOMY CATHETER2Cleared 510(K)
- 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
- 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
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K100842
- 510(k) Type
- Traditional
- Applicant
- HOTSPUR TECHNOLOGIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/12/2010
- Days to Decision
- 109 days
- Submission Type
- Summary