FDA 510(k) Applications for Medical Device Product Code "MJN"
(Catheter, Intravascular Occluding, Temporary)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221294 | Abiomed Inc. | preCARDIA Occlusion System | 06/30/2023 |
| K143613 | ACCESSCLOSURE, INC. | PaxWire Occlusion Balloon System | 08/14/2015 |
| K993248 | AGA MEDICAL CORP. | AMPLATZER SIZING BALLOON | 07/12/2000 |
| K053440 | AGA MEDICAL CORP. | AMPLATZER SIZING BALLOON II | 12/30/2005 |
| K192786 | Arch Catheter, LLC | Gatekeeper Balloon Catheter | 04/25/2020 |
| K021210 | ARTERIA MEDICAL SCIENCE, INC. | ARTERIA OCCLUSION BALLOON | 10/28/2002 |
| K001917 | ARTERIA MEDICAL SCIENCE, INC. | PARODI CATHETER FOR ANGIOGRAPHY (PARCA) | 06/06/2001 |
| K183045 | Balt USA, LLC | Eclipse 2L | 04/30/2019 |
| K140273 | BOSTON SCIENTIFIC CORP. | EQUALIZER OCCLUSION BALLOON CATHETER | 07/22/2014 |
| K132990 | BOSTON SCIENTIFIC CORP. | OCCLUSION BALLOON CATHETER | 10/22/2013 |
| K993292 | BOSTON SCIENTIFIC, TARGET | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER | 03/23/2000 |
| K964390 | CHASE MEDICAL, INC. | CHASE VESSEL OCCLUDER | 01/31/1997 |
| K023914 | COAXIA INC | COAXIA FLOCONTROL CATHETER | 02/21/2003 |
| K090970 | COAXIA, INC. | FLOCONTROL , MODEL 1028 | 06/12/2009 |
| K002286 | COOK, INC. | LDOB OCCLUSION BALLOON CATHETER | 03/22/2001 |
| K211610 | Edwards Lifesciences, LLC | Fogarty Occlusion Catheter | 02/14/2022 |
| K093911 | EDWARDS LIFESCIENCES, LLC. | FOGARTY OCCLUSION CATHETER | 01/21/2010 |
| K152762 | EDWARDS LIFESCIENCES, LLC. | Fogarty Occlusion Catheter | 11/23/2015 |
| K180904 | Embolx, Inc | Sniper Infusion Catheter with Balloon Occlusion | 06/08/2018 |
| K142692 | EMBOLX, INC. | Occlusion Balloon Catheter | 05/31/2015 |
| K100063 | EV3 INC | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL | 02/02/2010 |
| K090728 | EV3 INC. | HYPERGLIDE OCCLUSION BALLOON SYSTEM | 04/16/2009 |
| K091458 | EV3 NEUROVASCULAR | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 | 10/15/2009 |
| K092495 | EV3 NEUROVASCULAR | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 | 09/22/2009 |
| K201652 | Front Line Medical Technologies, Inc. | COBRA-OS Kit | 02/22/2021 |
| K960422 | IDEAS FOR MEDICINE, INC. | PRUITT SAFETY OCCLUSION CATHETER | 08/07/1996 |
| K960715 | IDEAS FOR MEDICINE, INC. | PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F | 09/09/1996 |
| K960832 | INTERVENTIONAL THERAPEUTICS CORP. | OCCLUSION BALLOON CATHETER | 05/29/1996 |
| K182916 | LeMaitre Vascular | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | 11/16/2018 |
| K143454 | LeMaitre Vascular, Inc | Pruitt F3-S Carotid Shunt | 08/27/2015 |
| K071367 | LEMAITRE VASCULAR, INC. | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 | 08/29/2007 |
| K132022 | LEMAITRE VASCULAR, INC. | LEMAITRE 8F OCCLUSION CATHETER | 11/06/2013 |
| K033159 | LEMAITRE VASCULAR, INC. | LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 | 12/19/2003 |
| K103356 | LEMAITRE VASCULAR, INC. | PRUITT CAROTID KIT | 12/08/2010 |
| K051067 | LEMAITRE VASCULAR, INC. | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) | 05/27/2005 |
| K152833 | LEMAITRE VASCULAR, INC. | Pruitt F3-S Polyurethane Carotid Shunt | 01/21/2016 |
| K043023 | LEMAITRE VASCULAR, INC. | PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 | 12/03/2004 |
| K955499 | LUCAS MEDICAL, INC. | LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER | 02/28/1996 |
| K983802 | LUCAS MEDICAL, INC. | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB | 07/30/1999 |
| K994141 | MEDTRONIC AVE, INC. | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 | 07/21/2000 |
| K101570 | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS | 07/13/2010 |
| K011535 | MICRO THERAPEUTICS, INC. | CADENCE PRECISION INJECTOR, MODEL 103-0304 | 08/02/2001 |
| K001237 | MICRO THERAPEUTICS, INC. | EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO | 05/18/2000 |
| K990487 | MICRO THERAPEUTICS, INC. | EQUINOX OCCLUSION BALLOON SYSTEM | 08/31/1999 |
| K010162 | MICRO THERAPEUTICS, INC. | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 | 05/18/2001 |
| K011656 | MICRO THERAPEUTICS, INC. | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 | 06/20/2001 |
| K011526 | MICRO THERAPEUTICS, INC. | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 | 06/14/2001 |
| K021066 | MICRO THERAPEUTICS, INC. | MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM | 06/18/2002 |
| K121785 | MICRO VENTION, INC. | SCEPTER C OCCLUSION BALLOON CATHETER | 08/10/2012 |
| K113698 | MICRO VENTION, INC. | SCEPTER XC OCCLUSION BALLOON CATHETER | 01/13/2012 |
| K110741 | MICROVENTION, INC. | SCEPTER C OCCLUSION BALLOON CATHETER | 09/29/2011 |
| K080861 | MICRUS ENDOVASCULAR CORPORATION | MICRUS ASCENT OCCLUSION BALLOON CATHETER | 08/27/2008 |
| K103780 | MICRUS ENDOVASCULAR CORPORATION | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | 01/26/2011 |
| K091504 | MICRUS ENDOVASCULAR CORPORATION | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 | 06/19/2009 |
| K210358 | Neurescue Aps | Neurescue device | 05/21/2021 |
| K041306 | NUMED, INC. | NUMED PTS X SIZING BALLOON CATHETER | 06/10/2004 |
| K003320 | NUMED, INC. | PTA-OS SIZING BALLOON, MODEL 360 | 05/02/2001 |
| K110903 | NUMED, INC. | PTS-X SIZING BALLOON CATHETER | 04/29/2011 |
| K131869 | NUMED, INC. | PTS-X SIZING BALLOON CATHETER | 08/08/2013 |
| K160598 | NUMED, INC. | REBOA Balloon Catheter | 06/20/2016 |
| K972777 | PERCUSURGE, INC. | TEMPORARY OCCLUSION BALLOON SYSTEM | 03/11/1998 |
| K081454 | POSSIS MEDICAL, INC. | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE | 06/13/2008 |
| K031357 | POSSIS MEDICAL, INC. | GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM | 05/18/2004 |
| K062220 | POSSIS MEDICAL, INC. | MODIFICATION TO GUARDDOG OCCLUSION SYSTEM | 08/11/2006 |
| K170411 | Prytime Medical Devices, Inc | ER-REBOA Catheter | 04/04/2017 |
| K193440 | Prytime Medical Devices, Inc | ER-REBOA PLUS Catheter | 01/09/2020 |
| K172790 | Prytime Medical Devices, Inc. | ER-REBOA Catheter | 11/08/2017 |
| K200459 | Prytime Medical Devices, Inc. | pREBOA-PRO Catheter | 06/03/2020 |
| K183679 | QXMedical, LLC | Occlusion Balloon Catheter | 04/24/2019 |
| K210602 | RenalPro Medical, Inc. | AortaSTAT Occlusion Device | 07/09/2021 |
| K191606 | RenovoRx, Inc. | RenovoCath | 08/07/2019 |
| K160067 | RenovoRx, Inc. | RenovoCath | 03/07/2017 |
| K212324 | RenovoRx, Inc. | RenovoCath | 08/23/2021 |
| K141175 | RENOVORX, INC. | RENOVOCATH RC120 | 10/24/2014 |
| K052844 | RICHTER & ROTHE AG | KAVS - CATHETER, MODELS 1107100 & 1107060 | 03/20/2006 |
| K153530 | SPECTRANETICS, INC. | Bridge Occlusion Balloon | 02/05/2016 |
| K203540 | Spectranetics, Inc. | Bridge Occlusion Balloon | 12/23/2020 |
| K122576 | STRYKER NEUROVASCULAR | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT | 01/11/2013 |
| K051137 | TECHDEVICE CORPORATION | TECHDEVICE OCCLUSION BALLOON CATHETER | 02/24/2006 |
| K093847 | THERMOPEUTIX INC. | DUFLO CATHETER (HEPARIN COATED) | 08/25/2010 |
| K080700 | THERMOPEUTIX INC. | DUOFLO CATHETER | 09/26/2008 |
| K112219 | THERMOPEUTIX INC. | TAPAS CATHETER | 11/18/2011 |
| K001621 | VASCUTECH, INC. | DARDIK CAROTID SHUNT | 12/06/2000 |
| K992942 | VASCUTECH, INC. | LEMAITRE OCCLUSION CATHETER | 04/13/2000 |
| K070770 | W. L. GORE & ASSOCIATES, INC. | GORE BALLOON SHEATH | 06/29/2007 |
| K172567 | W.L Gore And Associates Inc | GORE Molding and Occlusion Balloon Catheter | 01/31/2018 |
| K214060 | Zien Medical Technologies, Inc. | LANDMARK REBOA Catheter | 09/19/2022 |
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