510(k) K810859

SINGLE USE SELDINGER/COURNAND PERC. NDL by Procedure Products, Inc. — Product Code DRE

K810859 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "SINGLE USE SELDINGER/COURNAND PERC. NDL". The FDA issued a decision of Substantially Equivalent on April 11, 1981. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.