510(k) K253616

ProtekDilate Vascular Access Kit by Sorin Group Italia S.R.L. — Product Code DRE

K253616 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "ProtekDilate Vascular Access Kit". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.