LifeSPARC Pump, LifeSPARC Controller
FDA 510(k) clearance K183623 · decided 2019-07-09
Clearance details
- K-number
- K183623
- Device name
- LifeSPARC Pump, LifeSPARC Controller
- Applicant
- Cardiacassist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-07-09
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray recall (Z-2465-2023) | Cardiac Assist, Inc | 2023-08-25 |
| SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLL recall (Z-0926-2023) | Cardiac Assist, Inc | 2023-01-19 |
| TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Con recall (Z-1763-2022) | Cardiac Assist, Inc | 2022-09-23 |