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QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH S — Maquet Cardiopulmonary, AG (510(k) K1

QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH S — Maquet Cardiopulmonary, AG (510(k) K1 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH S; Applican

Device nameQUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH S
ApplicantMaquet Cardiopulmonary, AG
Clearance track510(k)
Submission numberK103191
DecisionSubstantially Equivalent
Decision date2011-03-08
Date received2010-10-28
Product codeDTZ
Device class2
Medical specialtyCardiovascular
Applicant locationDE
SourceopenFDA device

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