510(k) K093601 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
AF 840 PH.I.S.I.O. ARTERIAL FILTER
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Dec 18, 2009 |
| Received | Nov 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093601
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.