510(k) K964571 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
VISION CARDIOPLEGIA DELIVERY SYSTEM
| Applicant | Lifestream Int'L, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Aug 8, 1997 |
| Received | Nov 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964571
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.