510(k) K000977 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
| Applicant | Olson Medical Sales, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Mar 23, 2001 |
| Received | Mar 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2003 | Terumo Cardiovascular Systems Corp Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' . Terminated |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.