510(k) K980935 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
CAPIOX SX HARDSHELL RESERVOIR
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, May 14, 1998 |
| Received | Mar 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980935
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.