Cleared Traditional

ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012

K102109 · Eurosets Srl · Cardiovascular
Feb 2011
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K102109 is an FDA 510(k) clearance for the ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Eurosets Srl (Medolla, Modena, IT). The FDA issued a Cleared decision on February 15, 2011, 202 days after receiving the submission on July 28, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K102109 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2010
Decision Date February 15, 2011
Days to Decision 202 days
Submission Type Traditional
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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