K253616
- 510(k) number
- K253616
- Device name
- ProtekDilate Vascular Access Kit
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Decision date
- 2025-12-19
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253616.pdf
Official FDA record: K253616
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.