510(k) K031688 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
| Applicant | Guidant Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Jul 2, 2003 |
| Received | Jun 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031688
| 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.