510(k) K112525 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
| Applicant | Parexel International, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 29, 2011 |
| Received | Aug 31, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112525
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.