QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators

Oxygenator, Cardiopulmonary Bypass

MAQUET CARDIOPULMONARY AG

The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Adult/small Adult Oxygenators;quadrox-id Adult Oxygenators.

Pre-market Notification Details

Device IDK150267
510k NumberK150267
Device Name:QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt,  DE 76437
ContactWhitney Torning
CorrespondentWhitney Torning
MAQUET Cardiovascular 45 BARBOUR POND DRIVE Wayne,  NJ  07470
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-04
Decision Date2015-05-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04058863019192 K150267 000
04037692010594 K150267 000
04037692010570 K150267 000
04037692009925 K150267 000
04037692009932 K150267 000
04037692010556 K150267 000
04037692010563 K150267 000
04037692010532 K150267 000
04037692011379 K150267 000
04058863017358 K150267 000
04058863017389 K150267 000
04058863019000 K150267 000
04058863019024 K150267 000
04058863019062 K150267 000
04058863019086 K150267 000
04058863019154 K150267 000
04058863019178 K150267 000
04037692010471 K150267 000

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