TandemHeart Pump and Escort Controller
FDA 510(k) clearance K202751 · decided 2021-03-26
Clearance details
- K-number
- K202751
- Device name
- TandemHeart Pump and Escort Controller
- Applicant
- Cardiacassist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-21
- Decision date
- 2021-03-26
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- QNR
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pittsburg, PA, 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 |
| CentriMag™ Acute Circulatory Support System (K234118) | ABBOTT MEDICAL | 2024-01-26 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.