510(k) K993001 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Dec 3, 1999 |
| Received | Sep 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993001
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.