510(k) K901815

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY by Pioneering Technologies, Inc. — Product Code DRE

K901815 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY". The FDA issued a decision of Substantially Equivalent on July 3, 1990. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.