510(k) K833830 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
3-DAY BIOINDICATOR RELEASE PROCESS FOR
| Applicant | Shiley, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 12, 1984 |
| Received | Nov 7, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833830
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.