510(k) K142301

Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath by Cook Vascular, Inc. — Product Code DRE

K142301 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath". The FDA issued a decision of Substantially Equivalent on November 12, 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.