Cleared Traditional

ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)

K141492 · Eurosets Srl · Cardiovascular
Feb 2015
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K141492 is an FDA 510(k) clearance for the ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE), 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 6, 2015, 246 days after receiving the submission on June 5, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K141492 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2014
Decision Date February 06, 2015
Days to Decision 246 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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