510(k) K090878

MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) by Terumo Cardiovascular Systems Corp. — Product Code DWF

K090878 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)". The FDA issued a decision of Substantially Equivalent on April 3, 2009. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Terumo Cardiovascular Systems Corp. has at least 10 other 510(k) clearances on record.