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
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- K221294preCARDIA Occlusion System2Cleared 510(K)
- K214060LANDMARK REBOA Catheter2Cleared 510(K)
- K211610Fogarty Occlusion Catheter2Cleared 510(K)
- K212324RenovoCath2Cleared 510(K)
- K210602AortaSTAT Occlusion Device2Cleared 510(K)
- K210358Neurescue device2Cleared 510(K)
- K201652COBRA-OS Kit2Cleared 510(K)
- K203540Bridge Occlusion Balloon2Cleared 510(K)
- K200459pREBOA-PRO Catheter2Cleared 510(K)
- K192786Gatekeeper Balloon Catheter2Cleared 510(K)
- K193440ER-REBOA PLUS Catheter2Cleared 510(K)
- K191606RenovoCath2Cleared 510(K)
- K183045Eclipse 2L2Cleared 510(K)
- K183679Occlusion Balloon Catheter2Cleared 510(K)
- K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr2Cleared 510(K)
- K180904Sniper Infusion Catheter with Balloon Occlusion2Cleared 510(K)
- K172567GORE Molding and Occlusion Balloon Catheter2Cleared 510(K)
- K172790ER-REBOA Catheter2Cleared 510(K)
- K170411ER-REBOA Catheter2Cleared 510(K)
- K160067RenovoCath2Cleared 510(K)
- K160598REBOA Balloon Catheter2Cleared 510(K)
- K153530Bridge Occlusion Balloon2Cleared 510(K)
- K152833Pruitt F3-S Polyurethane Carotid Shunt2Cleared 510(K)
- K152762Fogarty Occlusion Catheter2Cleared 510(K)
- K143454Pruitt F3-S Carotid Shunt2Cleared 510(K)
- K143613PaxWire Occlusion Balloon System2Cleared 510(K)
- K142692Occlusion Balloon Catheter2Cleared 510(K)
- K141175RENOVOCATH RC1202Cleared 510(K)
- K140273EQUALIZER OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K132022LEMAITRE 8F OCCLUSION CATHETER2Cleared 510(K)
- K132990OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K131869PTS-X SIZING BALLOON CATHETER2Cleared 510(K)
- K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT2Cleared 510(K)
- K121785SCEPTER C OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K113698SCEPTER XC OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K112219TAPAS CATHETER2Cleared 510(K)
- K110741SCEPTER C OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K110903PTS-X SIZING BALLOON CATHETER2Cleared 510(K)
- K103780MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO2Cleared 510(K)
- K103356PRUITT CAROTID KIT2Cleared 510(K)
- K093847DUFLO CATHETER (HEPARIN COATED)2Cleared 510(K)
- K101570HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS2Cleared 510(K)
- K100063HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL2Cleared 510(K)
- K093911FOGARTY OCCLUSION CATHETER2Cleared 510(K)
- K091458HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,1042Cleared 510(K)
- K092495HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-43152Cleared 510(K)
- K091504MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 002Cleared 510(K)
- K090970FLOCONTROL , MODEL 10282Cleared 510(K)
- K090728HYPERGLIDE OCCLUSION BALLOON SYSTEM2Cleared 510(K)
- K080700DUOFLO CATHETER2Cleared 510(K)
- K080861MICRUS ASCENT OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K081454GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE2Cleared 510(K)
- K071367FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-052Cleared 510(K)
- K070770GORE BALLOON SHEATH2Cleared 510(K)
- K062220MODIFICATION TO GUARDDOG OCCLUSION SYSTEM2Cleared 510(K)
- K052844KAVS - CATHETER, MODELS 1107100 & 11070602Cleared 510(K)
- K051137TECHDEVICE OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K053440AMPLATZER SIZING BALLOON II2Cleared 510(K)
- K051067PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)2Cleared 510(K)
- K043023PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-492Cleared 510(K)
- K041306NUMED PTS X SIZING BALLOON CATHETER2Cleared 510(K)
- K031357GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM2Cleared 510(K)
- K033159LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-052Cleared 510(K)
- K023914COAXIA FLOCONTROL CATHETER2Cleared 510(K)
- K021210ARTERIA OCCLUSION BALLOON2Cleared 510(K)
- K021066MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM2Cleared 510(K)
- K011535CADENCE PRECISION INJECTOR, MODEL 103-03042Cleared 510(K)
- K011656HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-47712Cleared 510(K)
- K011526HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-41232Cleared 510(K)
- K001917PARODI CATHETER FOR ANGIOGRAPHY (PARCA)2Cleared 510(K)
- K010162EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-40262Cleared 510(K)
- K003320PTA-OS SIZING BALLOON, MODEL 3602Cleared 510(K)
- K002286LDOB OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K001621DARDIK CAROTID SHUNT2Cleared 510(K)
- K994141CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW10002Cleared 510(K)
- K993248AMPLATZER SIZING BALLOON2Cleared 510(K)
- K001237EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO2Cleared 510(K)
- K992942LEMAITRE OCCLUSION CATHETER2Cleared 510(K)
- K993292BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K990487EQUINOX OCCLUSION BALLOON SYSTEM2Cleared 510(K)
- K983802LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB2Cleared 510(K)
- K972777TEMPORARY OCCLUSION BALLOON SYSTEM2Cleared 510(K)
- K964390CHASE VESSEL OCCLUDER2Cleared 510(K)
- K960715PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F2Cleared 510(K)
- K960422PRUITT SAFETY OCCLUSION CATHETER2Cleared 510(K)
- K960832OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K955499LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER2Cleared 510(K)
- K915869RMI NORMOCLUDER CORONARY ARTERY OCCLUDER2Cleared 510(K)
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Bridge Occlusion Balloon
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K153530
- 510(k) Type
- Traditional
- Applicant
- SPECTRANETICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/5/2016
- Days to Decision
- 58 days
- Submission Type
- Summary