510(k) K082425 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
TANDEMHEART TRANSSEPTAL CANNULA- EF 72
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Sep 18, 2008 |
| Received | Aug 22, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082425
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.