Company
Cardiac Assist, Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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 | K183623 |
| 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 | K183623 |
| 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 | K183623 |
| Oct 14, 2021 | Cardiac Assist, Inc SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.
Including the following components:
a) 31 Fr ProtekDuo Veno-Venous Cannula Set
b) LifeSPARC Pump
c) 14Fr to 26 Fr Dil Open, Classified |
DWF | K160257 |
| Mar 19, 2021 | Cardiac Assist, Inc Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.
Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17
Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15
Catalog #: 5 Terminated |
DRE | K162181 |
| 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 | K110493 |
| 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 | K110493 |
| 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 | K110493 |
| 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 | K110493 |
| 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 | K110493 |
| 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 | K110493 |
| 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 | K110493 |
| 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 | K110493 |
| Nov 19, 2019 | Cardiac Assist, Inc TandemLife ECLS Procedure Kit - V24/A17, Catalog Number
5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s ven Terminated |
DWF | K162214 |
| Jan 10, 2011 | Cardiac Assist, Inc TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly
The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for Terminated |
DWF | K052570 |