510(k) K052381 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
| Applicant | Zerusa Limited, Galway, IE |
| Decision | Substantially Equivalent, Nov 21, 2005 |
| Received | Aug 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052381
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.