510(k) K083301

X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS by Terumo Cardiovascular Systems Corp. — Product Code DWF

K083301 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS". The FDA issued a decision of Substantially Equivalent on December 18, 2008. 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.