510(k) K012209 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | Jul 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012209
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.