510(k) K063255 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Jan 11, 2007 |
| Received | Oct 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063255
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.