Cleared Traditional

LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR

K971877 · Dideco S.P.A. · Cardiovascular
Oct 1997
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K971877 is an FDA 510(k) clearance for the LILLIPUT 2 INFANT 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 October 8, 1997, 140 days after receiving the submission on May 21, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K971877 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1997
Decision Date October 08, 1997
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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