Panels › Cardiovascular › Product code MJN · Class 2
Catheter, Intravascular Occluding, Temporary
Regulation 870.4450
0510(k)s in 12 months (90 all time)
0recalls in 12 months (21 all time)
20recalls that name a 510(k)
Top companies in MJN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2025 | K243795 | pREBOA-PRO Catheter Prytime Medical Devices, Inc. | MJN |
| Jun 24, 2025 | K251358 | Bridge Plus Occlusion Balloon (590-002) Philips Image Guided Therapy Devices | MJN |
| Jun 30, 2023 | K221294 | preCARDIA Occlusion System Abiomed, Inc. | MJN |
| Sep 19, 2022 | K214060 | LANDMARK REBOA Catheter Zien Medical Technologies, Inc. | MJN |
| Feb 14, 2022 | K211610 | Fogarty Occlusion Catheter Edwards Lifesciences, LLC | MJN |
| Aug 23, 2021 | K212324 | RenovoCath Renovorx, Inc. | MJN |
| Jul 9, 2021 | K210602 | AortaSTAT Occlusion Device Renalpro Medical, Inc. | MJN |
| May 21, 2021 | K210358 | Neurescue device Neurescue Aps, DK | MJN |
| Feb 22, 2021 | K201652 | COBRA-OS Kit Front Line Medical Technologies, Inc., CA | MJN |
| Dec 23, 2020 | K203540 | Bridge Occlusion Balloon Spectranetics, Inc. | MJN |
| Jun 3, 2020 | K200459 | pREBOA-PRO Catheter Prytime Medical Devices, Inc. | MJN |
| Apr 25, 2020 | K192786 | Gatekeeper Balloon Catheter Arch Catheter, LLC | MJN |
| Jan 9, 2020 | K193440 | ER-REBOA PLUS Catheter Prytime Medical Devices, Inc. | MJN |
| Aug 7, 2019 | K191606 | RenovoCath Renovorx, Inc. | MJN |
| Apr 30, 2019 | K183045 | Eclipse 2L Balt USA, LLC | MJN |
| Apr 24, 2019 | K183679 | Occlusion Balloon Catheter Qxmedical, LLC | MJN |
| Nov 16, 2018 | K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr Lemaitre Vascular | MJN |
| Jun 8, 2018 | K180904 | Sniper Infusion Catheter with Balloon Occlusion Embolx, Inc. | MJN |
| Jan 31, 2018 | K172567 | GORE Molding and Occlusion Balloon Catheter W. L. Gore and Associates, Inc. | MJN |
| Nov 8, 2017 | K172790 | ER-REBOA Catheter Prytime Medical Devices, Inc. | MJN |
| Apr 4, 2017 | K170411 | ER-REBOA Catheter Prytime Medical Devices, Inc. | MJN |
| Mar 7, 2017 | K160067 | RenovoCath Renovorx, Inc. | MJN |
| Jun 20, 2016 | K160598 | REBOA Balloon Catheter NuMED, Inc. | MJN |
| Feb 5, 2016 | K153530 | Bridge Occlusion Balloon Spectranetics, Inc. | MJN |
| Jan 21, 2016 | K152833 | Pruitt F3-S Polyurethane Carotid Shunt LeMaitre Vascular, Inc. | MJN |
| Nov 23, 2015 | K152762 | Fogarty Occlusion Catheter Edwards Lifesciences, LLC | MJN |
| Aug 27, 2015 | K143454 | Pruitt F3-S Carotid Shunt LeMaitre Vascular, Inc. | MJN |
| Aug 14, 2015 | K143613 | PaxWire Occlusion Balloon System Accessclosure, Inc. | MJN |
| May 31, 2015 | K142692 | Occlusion Balloon Catheter Embolx, Inc. | MJN |
| Oct 24, 2014 | K141175 | RENOVOCATH RC120 Renovorx, Inc. | MJN |
| Jul 22, 2014 | K140273 | EQUALIZER OCCLUSION BALLOON CATHETER Boston Scientific Corp | MJN |
| Nov 6, 2013 | K132022 | LEMAITRE 8F OCCLUSION CATHETER LeMaitre Vascular, Inc. | MJN |
| Oct 22, 2013 | K132990 | OCCLUSION BALLOON CATHETER Boston Scientific Corp | MJN |
| Aug 8, 2013 | K131869 | PTS-X SIZING BALLOON CATHETER NuMED, Inc. | MJN |
| Jan 11, 2013 | K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT Stryker Neurovascular | MJN |
| Aug 10, 2012 | K121785 | SCEPTER C OCCLUSION BALLOON CATHETER MicroVention, Inc. | MJN |
| Jan 13, 2012 | K113698 | SCEPTER XC OCCLUSION BALLOON CATHETER MicroVention, Inc. | MJN |
| Nov 18, 2011 | K112219 | TAPAS CATHETER Thermopeutix, Inc. | MJN |
| Sep 29, 2011 | K110741 | SCEPTER C OCCLUSION BALLOON CATHETER MicroVention, Inc. | MJN |
| Apr 29, 2011 | K110903 | PTS-X SIZING BALLOON CATHETER NuMED, Inc. | MJN |
| Jan 26, 2011 | K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO Micrus Endovascular Corporation | MJN |
| Dec 8, 2010 | K103356 | PRUITT CAROTID KIT LeMaitre Vascular, Inc. | MJN |
| Aug 25, 2010 | K093847 | DUFLO CATHETER (HEPARIN COATED) Thermopeutix, Inc. | MJN |
| Jul 13, 2010 | K101570 | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS Micro Therapeutics Dba Ev3 Neurovascular | MJN |
| Feb 2, 2010 | K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL Ev3, Inc. | MJN |
| Jan 21, 2010 | K093911 | FOGARTY OCCLUSION CATHETER Edwards Lifesciences, LLC | MJN |
| Oct 15, 2009 | K091458 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 Ev3 Neurovascular | MJN |
| Sep 22, 2009 | K092495 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 Ev3 Neurovascular | MJN |
| Jun 19, 2009 | K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 Micrus Endovascular Corporation | MJN |
| Jun 12, 2009 | K090970 | FLOCONTROL , MODEL 1028 Coaxia, Inc. | MJN |
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