510(k) K141148

EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET by Cook Vascular, Inc. — Product Code DRE

K141148 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET". The FDA issued a decision of Substantially Equivalent on July 1, 2014. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Cook Vascular, Inc. has at least 10 other 510(k) clearances on record.