Cleared Special

LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902

K001021 · Dideco S.P.A. · Cardiovascular
Apr 2000
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K001021 is an FDA 510(k) clearance for the LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902, 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 April 25, 2000, 26 days after receiving the submission on March 30, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K001021 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2000
Decision Date April 25, 2000
Days to Decision 26 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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