510(k) K162181

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set by Cardiacassist, Inc. — Product Code DRE

K162181 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.