INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY

About This 510(k) Submission

K022450 is an FDA 510(k) clearance for the INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on October 22, 2002, 88 days after receiving the submission on July 26, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.