510(k) K892377 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
| Applicant | Research Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 7, 1989 |
| Received | Apr 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2010 | Edwards Lifesciences Llc Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614 Terminated |
DTL | None listed |
| Dec 7, 2010 | Edwards Lifesciences Llc Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614. Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.