510(k) K052570 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jan 17, 2006 |
| Received | Sep 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.