Cleared Special

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

K020351 · Dideco S.P.A. · Cardiovascular
Feb 2002
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K020351 is an FDA 510(k) clearance for the D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER 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 February 26, 2002, 22 days after receiving the submission on February 4, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K020351 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2002
Decision Date February 26, 2002
Days to Decision 22 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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