510(k) K897039 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
| Applicant | 3M Company, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Mar 16, 1990 |
| Received | Dec 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897039
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Cardioplegia Delivery Sets
Catalog Code: 204880
Product Usage:
This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the sub Terminated |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.