Cleared Traditional

AMG PMP Pediatric

K202206 · Eurosets Srl · Cardiovascular
Apr 2021
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K202206 is an FDA 510(k) clearance for the AMG PMP Pediatric, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Eurosets Srl (Medolla, IT). The FDA issued a Cleared decision on April 1, 2021, 239 days after receiving the submission on August 5, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K202206 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2020
Decision Date April 01, 2021
Days to Decision 239 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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