510(k) K851003 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
| Applicant | Gish Biomedical, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jul 29, 1985 |
| Received | Mar 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851003
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.