510(k) K093986 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Jan 22, 2010 |
| Received | Dec 24, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093986
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.