Cleared Traditional

OXY-1 System

K200109 · Abiomed, Inc. · Cardiovascular
Oct 2020
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K200109 is an FDA 510(k) clearance for the OXY-1 System, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on October 23, 2020, 280 days after receiving the submission on January 17, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K200109 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2020
Decision Date October 23, 2020
Days to Decision 280 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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