CentriMag™ Acute Circulatory Support System
FDA 510(k) clearance K234118 · decided 2024-01-26
Clearance details
- K-number
- K234118
- Device name
- CentriMag™ Acute Circulatory Support System
- Applicant
- ABBOTT MEDICAL
- Decision
- Substantially Equivalent
- Date received
- 2023-12-28
- Decision date
- 2024-01-26
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- QNR
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pleasanton, 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 |
|---|---|---|
| VitalFlow Console (K250199) | Medtronic, Inc. | 2025-05-20 |
| LifeSPARC System (K233736) | Cardiacassist, Inc. | 2024-01-19 |
| VitalFlow™ Console (K230364) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| VitalFlowTM Centrifugal Pump (K223898) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038) | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| LifeSPARC System (K211830) | Cardiacassist, Inc. | 2022-11-15 |
| TandemHeart Pump and Escort Controller (K202751) | Cardiacassist, Inc. | 2021-03-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092) | ABBOTT MEDICAL | 2025-12-23 |
| Proclaim Spinal Cord Stimulation (SCS) System (P010032/S246) | ABBOTT MEDICAL | 2025-12-23 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S127) | ABBOTT MEDICAL | 2025-12-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S014) | ABBOTT MEDICAL | 2025-12-23 |
| Volt PFA System (P250022) | ABBOTT MEDICAL | 2025-12-19 |
| HeartMate II Left Ventricular Assist System (P060040/S122) | ABBOTT MEDICAL | 2025-12-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S116) | ABBOTT MEDICAL | 2025-12-17 |
| Durata Leads; Optisure Leads (P950022/S151) | ABBOTT MEDICAL | 2025-12-09 |