preCARDIA Occlusion System
FDA 510(k) clearance K221294 · decided 2023-06-30
Clearance details
- K-number
- K221294
- Device name
- preCARDIA Occlusion System
- Applicant
- Abiomed, Inc.
- Decision
- Unknown
- Date received
- 2022-05-04
- Decision date
- 2023-06-30
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, 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 |
| LANDMARK REBOA Catheter (K214060) | Zien Medical Technologies, Inc. | 2022-09-19 |
| Fogarty Occlusion Catheter (K211610) | Edwards Lifesciences, LLC | 2022-02-14 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P140003/S136) | Abiomed, Inc. | 2025-12-19 |
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P170011/S062) | Abiomed, Inc. | 2025-12-19 |
| Impella 5.5 with SmartAssist (P140003/S131) | Abiomed, Inc. | 2025-10-01 |
| Impella CP with SmartAssist (P140003/S130) | Abiomed, Inc. | 2025-09-24 |
| Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (P140003/S129) | Abiomed, Inc. | 2025-09-19 |
| Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S060) | Abiomed, Inc. | 2025-09-19 |
| Purge Cassette (P170011/S058) | Abiomed, Inc. | 2025-09-15 |
| Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (P140003/S126) | Abiomed, Inc. | 2025-09-15 |