MJN — Catheter, Intravascular Occluding, Temporary Class II
FDA product code MJN covers "Catheter, Intravascular Occluding, Temporary", a Class II medical device regulated under 21 CFR 870.4450. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |