510(k) K953945

RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET by Dlp, Inc. — Product Code DWF

K953945 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET". The FDA issued a decision of Substantially Equivalent on March 26, 1996. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Dlp, Inc. has at least 10 other 510(k) clearances on record.