510(k) K894684

PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT by Pioneering Technologies, Inc. — Product Code DWF

K894684 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT". The FDA issued a decision of Substantially Equivalent on October 17, 1989. 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.