510(k) K253616 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
ProtekDilate Vascular Access Kit
| Applicant | Sorin Group Italia S.R.L., Mirandola ( Modena), IT |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Nov 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253616
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.