510(k) K883221

PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT by Pioneering Technologies, Inc. — Product Code DWF

K883221 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.