Cleared Special

EOS PMP

K211495 · Sorin Group Italia S.R.L. · Cardiovascular
Jul 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K211495 is an FDA 510(k) clearance for the EOS PMP, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on July 12, 2021, 60 days after receiving the submission on May 13, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K211495 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2021
Decision Date July 12, 2021
Days to Decision 60 days
Submission Type Special
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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