510(k) K061000

EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 by Cook Vascular, Inc. — Product Code DRE

K061000 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0". The FDA issued a decision of Substantially Equivalent on May 10, 2006. 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.