510(k) K010055

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH by Cook Vascular, Inc. — Product Code DRE

K010055 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH". The FDA issued a decision of Substantially Equivalent on June 14, 2001. 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.