510(k) K003604 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
ADAPTERS WITH X-COATING
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Feb 7, 2001 |
| Received | Nov 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003604
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.