510(k) K853516 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 14, 1985 |
| Received | Aug 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853516
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.