510(k) K843261

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD by Angiosystems, Inc. — Product Code DRE

K843261 is an FDA 510(k) premarket notification submitted by Angiosystems, Inc. for the device "ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Angiosystems, Inc. has at least 10 other 510(k) clearances on record.