Cleared Special

SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

K031223 · Dideco S.P.A. · Cardiovascular
May 2003
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K031223 is an FDA 510(k) clearance for the SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR, 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 May 2, 2003, 14 days after receiving the submission on April 18, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K031223 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2003
Decision Date May 02, 2003
Days to Decision 14 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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