Cleared Abbreviated

D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING

K033323 · Dideco S.P.A. · Cardiovascular
Jan 2004
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K033323 is an FDA 510(k) clearance for the D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING, 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 January 13, 2004, 90 days after receiving the submission on October 15, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K033323 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2003
Decision Date January 13, 2004
Days to Decision 90 days
Submission Type Abbreviated
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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