510(k) K031903 ยท DTZ Oxygenator, Cardiopulmonary Bypass
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
| Applicant | Guidant Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Mar 3, 2004 |
| Received | Jun 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031903
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2011 | Abbott Vascular Guidant RAPIDO Cut-Away Guiding Catheter, 6F.
Part Numbers: 66676-201 and 667552-100.
For use in cardiac diagnostic and therapeutic procedures. Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.