510(k) K882879

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) by Pioneering Technologies, Inc. — Product Code DXC

K882879 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)". The FDA issued a decision of Substantially Equivalent on September 12, 1988. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.