Product code MJN
- Device name
- Catheter, Intravascular Occluding, Temporary
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4450
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2025-09-05 |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | 2025-06-24 |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | 2023-06-30 |
| K214060 | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | 2022-09-19 |
| K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2022-02-14 |
| K212324 | RenovoCath | Renovorx, Inc. | 2021-08-23 |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | 2021-07-09 |
| K210358 | Neurescue device | Neurescue Aps | 2021-05-21 |
| K201652 | COBRA-OS Kit | Front Line Medical Technologies, Inc. | 2021-02-22 |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020-12-23 |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020-06-03 |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020-04-25 |
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | 2020-01-09 |
| K191606 | RenovoCath | Renovorx, Inc. | 2019-08-07 |
| K183045 | Eclipse 2L | Balt USA, LLC | 2019-04-30 |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019-04-24 |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | Lemaitre Vascular | 2018-11-16 |
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | 2018-06-08 |
| K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | 2018-01-31 |
| K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-11-08 |
| K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-04-04 |
| K160067 | RenovoCath | Renovorx, Inc. | 2017-03-07 |
| K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016-06-20 |
| K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016-02-05 |
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | LeMaitre Vascular, Inc. | 2016-01-21 |
| K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2015-11-23 |
| K143454 | Pruitt F3-S Carotid Shunt | LeMaitre Vascular, Inc. | 2015-08-27 |
| K143613 | PaxWire Occlusion Balloon System | Accessclosure, Inc. | 2015-08-14 |
| K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015-05-31 |
| K141175 | RENOVOCATH RC120 | Renovorx, Inc. | 2014-10-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810060550816 | Bridge Plus occlusion balloon | Philips Image Guided Therapy Corporation | 2025-10-09 |
| 00850001105118 | Prytime Medical Devices, Inc. | Prytime Medical Devices, Inc. | 2025-06-20 |
| 00842429117583 | SCEPTER | Microvention, Inc. | 2025-04-30 |
| 00842429117545 | SCEPTER | Microvention, Inc. | 2025-04-30 |
| 00842429106945 | Balloon Catheter | Microvention, Inc. | 2025-04-22 |
| B090LRN0590 | LANDMARK | ZIEN MEDICAL TECHNOLOGIES, INC. | 2024-01-23 |
| 20763000293424 | Cadence ™ Precision Injector Thread 1 mL Syringe | Micro Therapeutics, Inc. | 2022-12-23 |
| 00850001105057 | Prytime Medical Devices Inc. | Prytime Medical Devices, Inc. | 2022-12-15 |
| 00850001105064 | Prytime Medical Devices, Inc. | Prytime Medical Devices, Inc. | 2022-12-15 |
| 00842429103395 | Balloon Catheter | Microvention, Inc. | 2022-06-14 |
| 00842429103401 | Balloon Catheter | Microvention, Inc. | 2022-06-14 |
| 00842429103418 | Balloon Catheter | Microvention, Inc. | 2022-06-14 |
| 00842429106563 | Balloon Catheter | Microvention, Inc. | 2022-06-14 |
| B3808FCES300 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B3809FCES150 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B3809FCES300 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B38011FCES300 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B38011FCES150 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B3808FCES150 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B38012FCES300 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B38010FCES300 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B38010FCES150 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| B38012FCES150 | CAROTID ENDARTERECTOMY SHUNT | LUCAS MEDICAL INC | 2019-07-22 |
| 00818053023002 | ECLIPSE 2L | BALT USA LLC | 2019-07-15 |
| 00818053022968 | ECLIPSE 2L | BALT USA LLC | 2019-07-15 |
| 00818053022920 | ECLIPSE 2L | BALT USA LLC | 2019-07-15 |
| 00853892004072 | Q50X | QXMEDICAL | 2019-01-23 |
| 00853892004089 | Q50X | QXMEDICAL | 2019-01-23 |
| 00853892004003 | Q50 Plus | QXMEDICAL | 2016-06-08 |
| 00853892004010 | Q50 Plus | QXMEDICAL | 2016-06-08 |