MJN — Catheter, Intravascular Occluding, Temporary Class II
FDA Device Classification
Classification Details
- Product Code
- MJN
- Device Class
- Class II
- Regulation Number
- 870.4450
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243795 | prytime medical devices | pREBOA-PRO Catheter | September 5, 2025 |
| K251358 | philips image guided therapy devices | Bridge Plus Occlusion Balloon (590-002) | June 24, 2025 |
| K221294 | abiomed | preCARDIA Occlusion System | June 30, 2023 |
| K214060 | zien medical technologies | LANDMARK REBOA Catheter | September 19, 2022 |
| K211610 | edwards lifesciences | Fogarty Occlusion Catheter | February 14, 2022 |
| K212324 | renovorx | RenovoCath | August 23, 2021 |
| K210602 | renalpro medical | AortaSTAT Occlusion Device | July 9, 2021 |
| K210358 | neurescue aps | Neurescue device | May 21, 2021 |
| K201652 | front line medical technologies | COBRA-OS Kit | February 22, 2021 |
| K203540 | spectranetics | Bridge Occlusion Balloon | December 23, 2020 |
| K200459 | prytime medical devices | pREBOA-PRO Catheter | June 3, 2020 |
| K192786 | arch catheter | Gatekeeper Balloon Catheter | April 25, 2020 |
| K193440 | prytime medical devices | ER-REBOA PLUS Catheter | January 9, 2020 |
| K191606 | renovorx | RenovoCath | August 7, 2019 |
| K183045 | balt usa | Eclipse 2L | April 30, 2019 |
| K183679 | qxmedical | Occlusion Balloon Catheter | April 24, 2019 |
| K182916 | lemaitre vascular | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid | November 16, 2018 |
| K180904 | embolx | Sniper Infusion Catheter with Balloon Occlusion | June 8, 2018 |
| K172567 | w. l. gore and associates | GORE Molding and Occlusion Balloon Catheter | January 31, 2018 |
| K172790 | prytime medical devices | ER-REBOA Catheter | November 8, 2017 |