FDA Product Code
FDA Product Code MJN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4450
510(k) Clearances — 90 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2025-09-05 | Traditional | PDF ↗ |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | 2025-06-24 | Traditional | PDF ↗ |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | 2023-06-30 | Traditional | PDF ↗ |
| K214060 | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | 2022-09-19 | Traditional | PDF ↗ |
| K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2022-02-14 | Traditional | PDF ↗ |
| K212324 | RenovoCath | Renovorx, Inc. | 2021-08-23 | Special | PDF ↗ |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | 2021-07-09 | Traditional | PDF ↗ |
| K210358 | Neurescue device | Neurescue Aps | 2021-05-21 | Traditional | PDF ↗ |
| K201652 | COBRA-OS Kit | Front Line Medical Technologies, Inc. | 2021-02-22 | Traditional | PDF ↗ |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020-12-23 | Special | PDF ↗ |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020-06-03 | Traditional | PDF ↗ |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020-04-25 | Traditional | PDF ↗ |
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | 2020-01-09 | Special | PDF ↗ |
| K191606 | RenovoCath | Renovorx, Inc. | 2019-08-07 | Traditional | PDF ↗ |
| K183045 | Eclipse 2L | Balt USA, LLC | 2019-04-30 | Traditional | PDF ↗ |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019-04-24 | Traditional | PDF ↗ |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | Lemaitre Vascular | 2018-11-16 | Special | PDF ↗ |
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | 2018-06-08 | Traditional | PDF ↗ |
| K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | 2018-01-31 | Traditional | PDF ↗ |
| K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-11-08 | Traditional | PDF ↗ |
| K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-04-04 | Traditional | PDF ↗ |
| K160067 | RenovoCath | Renovorx, Inc. | 2017-03-07 | Traditional | PDF ↗ |
| K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016-06-20 | Traditional | PDF ↗ |
| K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016-02-05 | Traditional | PDF ↗ |
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | LeMaitre Vascular, Inc. | 2016-01-21 | Traditional | PDF ↗ |
| K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2015-11-23 | Traditional | PDF ↗ |
| K143454 | Pruitt F3-S Carotid Shunt | LeMaitre Vascular, Inc. | 2015-08-27 | Traditional | PDF ↗ |
| K143613 | PaxWire Occlusion Balloon System | Accessclosure, Inc. | 2015-08-14 | Traditional | PDF ↗ |
| K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015-05-31 | Traditional | PDF ↗ |
| K141175 | RENOVOCATH RC120 | Renovorx, Inc. | 2014-10-24 | Traditional | PDF ↗ |
| K140273 | EQUALIZER OCCLUSION BALLOON CATHETER | Boston Scientific Corp | 2014-07-22 | Traditional | PDF ↗ |
| K132022 | LEMAITRE 8F OCCLUSION CATHETER | LeMaitre Vascular, Inc. | 2013-11-06 | Traditional | PDF ↗ |
| K132990 | OCCLUSION BALLOON CATHETER | Boston Scientific Corp | 2013-10-22 | Special | PDF ↗ |
| K131869 | PTS-X SIZING BALLOON CATHETER | NuMED, Inc. | 2013-08-08 | Special | PDF ↗ |
| K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT | Stryker Neurovascular | 2013-01-11 | Traditional | PDF ↗ |
| K121785 | SCEPTER C OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2012-08-10 | Traditional | PDF ↗ |
| K113698 | SCEPTER XC OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2012-01-13 | Special | PDF ↗ |
| K112219 | TAPAS CATHETER | Thermopeutix, Inc. | 2011-11-18 | Traditional | PDF ↗ |
| K110741 | SCEPTER C OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2011-09-29 | Traditional | PDF ↗ |
| K110903 | PTS-X SIZING BALLOON CATHETER | NuMED, Inc. | 2011-04-29 | Special | PDF ↗ |
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | Micrus Endovascular Corporation | 2011-01-26 | Special | PDF ↗ |
| K103356 | PRUITT CAROTID KIT | LeMaitre Vascular, Inc. | 2010-12-08 | Special | PDF ↗ |
| K093847 | DUFLO CATHETER (HEPARIN COATED) | Thermopeutix, Inc. | 2010-08-25 | Special | PDF ↗ |
| K101570 | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS | Micro Therapeutics Dba Ev3 Neurovascular | 2010-07-13 | Traditional | PDF ↗ |
| K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL | Ev3, Inc. | 2010-02-02 | Special | PDF ↗ |
| K093911 | FOGARTY OCCLUSION CATHETER | Edwards Lifesciences, LLC | 2010-01-21 | Special | PDF ↗ |
| K091458 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 | Ev3 Neurovascular | 2009-10-15 | Traditional | PDF ↗ |
| K092495 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 | Ev3 Neurovascular | 2009-09-22 | Special | PDF ↗ |
| K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 | Micrus Endovascular Corporation | 2009-06-19 | Special | PDF ↗ |
| K090970 | FLOCONTROL , MODEL 1028 | Coaxia, Inc. | 2009-06-12 | Traditional | PDF ↗ |
| K090728 | HYPERGLIDE OCCLUSION BALLOON SYSTEM | Ev3, Inc. | 2009-04-16 | Special | PDF ↗ |
| K080700 | DUOFLO CATHETER | Thermopeutix, Inc. | 2008-09-26 | Traditional | PDF ↗ |
| K080861 | MICRUS ASCENT OCCLUSION BALLOON CATHETER | Micrus Endovascular Corporation | 2008-08-27 | Traditional | PDF ↗ |
| K081454 | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE | Possis Medical, Inc. | 2008-06-13 | Special | PDF ↗ |
| K071367 | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 | LeMaitre Vascular, Inc. | 2007-08-29 | Special | PDF ↗ |
| K070770 | GORE BALLOON SHEATH | W. L. Gore & Associates, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K062220 | MODIFICATION TO GUARDDOG OCCLUSION SYSTEM | Possis Medical, Inc. | 2006-08-11 | Special | PDF ↗ |
| K052844 | KAVS - CATHETER, MODELS 1107100 & 1107060 | Richter & Rothe AG | 2006-03-20 | Traditional | PDF ↗ |
| K051137 | TECHDEVICE OCCLUSION BALLOON CATHETER | Techdevice Corporation | 2006-02-24 | Traditional | PDF ↗ |
| K053440 | AMPLATZER SIZING BALLOON II | Aga Medical Corp. | 2005-12-30 | Special | PDF ↗ |
| K051067 | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) | LeMaitre Vascular, Inc. | 2005-05-27 | Special | PDF ↗ |
| K043023 | PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 | LeMaitre Vascular, Inc. | 2004-12-03 | Special | PDF ↗ |
| K041306 | NUMED PTS X SIZING BALLOON CATHETER | NuMED, Inc. | 2004-06-10 | Special | PDF ↗ |
| K031357 | GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM | Possis Medical, Inc. | 2004-05-18 | Traditional | PDF ↗ |
| K033159 | LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 | LeMaitre Vascular, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K023914 | COAXIA FLOCONTROL CATHETER | Coaxia, Inc. | 2003-02-21 | Traditional | PDF ↗ |
| K021210 | ARTERIA OCCLUSION BALLOON | Arteria Medical Science, Inc. | 2002-10-28 | Traditional | PDF ↗ |
| K021066 | MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM | Micro Therapeutics, Inc. | 2002-06-18 | Traditional | PDF ↗ |
| K011535 | CADENCE PRECISION INJECTOR, MODEL 103-0304 | Micro Therapeutics, Inc. | 2001-08-02 | Abbreviated | PDF ↗ |
| K011656 | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 | Micro Therapeutics, Inc. | 2001-06-20 | Special | PDF ↗ |
| K011526 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 | Micro Therapeutics, Inc. | 2001-06-14 | Special | PDF ↗ |
| K001917 | PARODI CATHETER FOR ANGIOGRAPHY (PARCA) | Arteria Medical Science, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K010162 | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 | Micro Therapeutics, Inc. | 2001-05-18 | Traditional | PDF ↗ |
| K003320 | PTA-OS SIZING BALLOON, MODEL 360 | NuMED, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K002286 | LDOB OCCLUSION BALLOON CATHETER | Cook, Inc. | 2001-03-22 | Traditional | PDF ↗ |
| K001621 | DARDIK CAROTID SHUNT | Vascutech, Inc. | 2000-12-06 | Traditional | PDF ↗ |
| K994141 | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 | Medtronic Ave, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K993248 | AMPLATZER SIZING BALLOON | Aga Medical Corp. | 2000-07-12 | Traditional | PDF ↗ |
| K001237 | EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO | Micro Therapeutics, Inc. | 2000-05-18 | Special | PDF ↗ |
| K992942 | LEMAITRE OCCLUSION CATHETER | Vascutech, Inc. | 2000-04-13 | Traditional | PDF ↗ |
| K993292 | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER | Boston Scientific, Target | 2000-03-23 | Traditional | PDF ↗ |
| K990487 | EQUINOX OCCLUSION BALLOON SYSTEM | Micro Therapeutics, Inc. | 1999-08-31 | Traditional | PDF ↗ |
| K983802 | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB | Lucas Medical, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K972777 | TEMPORARY OCCLUSION BALLOON SYSTEM | Percu Surge, Inc. | 1998-03-11 | Traditional | PDF ↗ |
| K964390 | CHASE VESSEL OCCLUDER | Chase Medical, Inc. | 1997-01-31 | Traditional | PDF ↗ |
| K960715 | PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F | Ideas For Medicine, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K960422 | PRUITT SAFETY OCCLUSION CATHETER | Ideas For Medicine, Inc. | 1996-08-07 | Traditional | PDF ↗ |
| K960832 | OCCLUSION BALLOON CATHETER | Interventional Therapeutics Corp. | 1996-05-29 | Traditional | PDF ↗ |
| K955499 | LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER | Lucas Medical, Inc. | 1996-02-28 | Traditional | PDF ↗ |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | Research Medical, Inc. | 1992-12-08 | Traditional | PDF ↗ |
Product code MJN · Class II · Cardiovascular. Data: openFDA.