510(k) K242953 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
KIDS Arterial Filters
| Applicant | Sorin Group Italia S.R.L., Mirandola (Modena), IT |
| Decision | Substantially Equivalent, Dec 20, 2024 |
| Received | Sep 25, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242953
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.