D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER

About This 510(k) Submission

K013915 is an FDA 510(k) clearance for the D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Dideco S.P.A. (Arvada, US). The FDA issued a Cleared decision on December 27, 2001, 30 days after receiving the submission on November 27, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.