510(k) K962981 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
CAPIOX SP PUMP HEAD
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Aug 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2005 | Terumo Cardiovascular Systems Corp Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump
The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and oth Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.