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