510(k) K860523 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
CARDIO-COOL
| Applicant | Bio-Vascular, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 29, 1986 |
| Received | Feb 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860523
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.