Cleared Traditional

OXY-1 System

K223161 · Abiomed, Inc. · Cardiovascular
Feb 2023
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K223161 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 February 23, 2023, 139 days after receiving the submission on October 7, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K223161 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2022
Decision Date February 23, 2023
Days to Decision 139 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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