Fogarty Occlusion Catheter
FDA 510(k) clearance K211610 · decided 2022-02-14
Clearance details
- K-number
- K211610
- Device name
- Fogarty Occlusion Catheter
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-05-25
- Decision date
- 2022-02-14
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| pREBOA-PRO Catheter (K243795) | Prytime Medical Devices, Inc. | 2025-09-05 |
| Bridge Plus Occlusion Balloon (590-002) (K251358) | Philips Image Guided Therapy Devices | 2025-06-24 |
| preCARDIA Occlusion System (K221294) | Abiomed, Inc. | 2023-06-30 |
| LANDMARK REBOA Catheter (K214060) | Zien Medical Technologies, Inc. | 2022-09-19 |
| RenovoCath (K212324) | Renovorx, Inc. | 2021-08-23 |
| AortaSTAT Occlusion Device (K210602) | Renalpro Medical, Inc. | 2021-07-09 |
| Neurescue device (K210358) | Neurescue Aps | 2021-05-21 |
| COBRA-OS Kit (K201652) | Front Line Medical Technologies, Inc. | 2021-02-22 |
| Bridge Occlusion Balloon (K203540) | Spectranetics, Inc. | 2020-12-23 |
| pREBOA-PRO Catheter (K200459) | Prytime Medical Devices, Inc. | 2020-06-03 |
| Gatekeeper Balloon Catheter (K192786) | Arch Catheter, LLC | 2020-04-25 |
| ER-REBOA PLUS Catheter (K193440) | Prytime Medical Devices, Inc. | 2020-01-09 |
Recalls involving this device
No recalls on record reference this clearance.