Cleared Traditional

CentriMag Pre-connected Pack

K222297 · Abbott · Cardiovascular
Dec 2022
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K222297 is an FDA 510(k) clearance for the CentriMag Pre-connected Pack, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Abbott (Pleasnaton, US). The FDA issued a Cleared decision on December 1, 2022, 122 days after receiving the submission on August 1, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K222297 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2022
Decision Date December 01, 2022
Days to Decision 122 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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