Cleared Traditional

K150267 - QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
(FDA 510(k) Clearance)

K150267 · Maquet Cardiopulmonary, AG · Cardiovascular
May 2015
Decision
92d
Days
Class 2
Risk

K150267 is an FDA 510(k) clearance for the QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on May 7, 2015, 92 days after receiving the submission on February 4, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K150267 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2015
Decision Date May 07, 2015
Days to Decision 92 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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