510(k) K073620 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
GUARDIAN HEMOSTASIS VALVE
| Applicant | Zerusa Limited, Galway, IE |
| Decision | Substantially Equivalent, Feb 27, 2008 |
| Received | Dec 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073620
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.