510(k) K072308 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Sep 12, 2007 |
| Received | Aug 17, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072308
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.