Submission Details
| 510(k) Number | K253616 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ProtekDilate Vascular Access Kit
Dec 2025
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K253616 is an FDA 510(k) clearance for the ProtekDilate Vascular Access Kit, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Sorin Group Italia S.R.L. (Mirandola ( Modena), IT). The FDA issued a Cleared decision on December 19, 2025, 31 days after receiving the submission on November 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.
Device Classification
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1310 |
Manufacturer
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