510(k) K110493 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
TANDEMHEART PUMP
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Sep 20, 2011 |
| Received | Feb 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locall Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to local Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally de Terminated |
KFM | None listed |
| Mar 6, 2020 | Cardiac Assist, Inc TandemHeart pump is assembled into kits: TandemLife Kit
Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver a Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.