510(k) K012898 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Sep 17, 2001 |
| Received | Aug 29, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012898
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.