510(k) K982254 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Sep 10, 1998 |
| Received | Jun 26, 1998 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K982254
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.