510(k) K004046 ยท DTP Defoamer, Cardiopulmonary Bypass
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Apr 26, 2001 |
| Received | Dec 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004046
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.