510(k) K183623 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
LifeSPARC Pump, LifeSPARC Controller
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jul 9, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2023 | Cardiac Assist, Inc LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000.
Note: The 5800-1000 model number is an individually packaged component contained wit Open, Classified |
KFM | None listed |
| Jan 19, 2023 | Cardiac Assist, Inc SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000;
SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit Terminated |
DWA | None listed |
| Sep 23, 2022 | Cardiac Assist, Inc TANDEM LIFE LivaNova LIFESPARC Controller;
Controller and Accessories Model 5900-0000;
Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass. Terminated |
DWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.