Cleared Traditional

AMG PMP Infant

K202510 · Eurosets Srl · Cardiovascular
Dec 2021
Decision
466d
Days
Class 2
Risk

About This 510(k) Submission

K202510 is an FDA 510(k) clearance for the AMG PMP Infant, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Eurosets Srl (Medolla, IT). The FDA issued a Cleared decision on December 10, 2021, 466 days after receiving the submission on August 31, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K202510 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2020
Decision Date December 10, 2021
Days to Decision 466 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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