510(k) K001138 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
| Applicant | Medtronic Vascular, Anaheim CA, US |
| Decision | Substantially Equivalent, Apr 27, 2000 |
| Received | Apr 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001138
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.