MJN · Catheter, Intravascular Occluding, Temporary
Cardiovascular · 21 CFR 870.4450 · Class 2
Overview
| Product Code | MJN |
|---|---|
| Device Name | Catheter, Intravascular Occluding, Temporary |
| Regulation | 21 CFR 870.4450 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 90)
Showing 20 most recent of 90 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | Sep 5, 2025 | SESE |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | Jun 24, 2025 | SESE |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | Jun 30, 2023 | SESU |
| K214060 | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | Sep 19, 2022 | SESE |
| K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | Feb 14, 2022 | SESE |
| K212324 | RenovoCath | Renovorx, Inc. | Aug 23, 2021 | SESE |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | Jul 9, 2021 | SESE |
| K210358 | Neurescue device | Neurescue Aps | May 21, 2021 | SESE |
| K201652 | COBRA-OS Kit | Front Line Medical Technologies, Inc. | Feb 22, 2021 | SESK |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | Dec 23, 2020 | SESE |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | Jun 3, 2020 | SESE |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | Apr 25, 2020 | SESE |
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | Jan 9, 2020 | SESE |
| K191606 | RenovoCath | Renovorx, Inc. | Aug 7, 2019 | SESE |
| K183045 | Eclipse 2L | Balt USA, LLC | Apr 30, 2019 | SESE |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | Apr 24, 2019 | SESE |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | Lemaitre Vascular | Nov 16, 2018 | SESE |
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | Jun 8, 2018 | SESE |
| K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | Jan 31, 2018 | SESE |
| K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | Nov 8, 2017 | SESE |
Top Applicants
- LeMaitre Vascular, Inc. — 8 clearances
- Micro Therapeutics, Inc. — 7 clearances
- Prytime Medical Devices, Inc. — 5 clearances
- NuMED, Inc. — 5 clearances
- Renovorx, Inc. — 4 clearances
