QUADROX-I, QUADROX-ID, QUADROX-IR 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, Quadrox-id, Quadrox-ir Oxygenators.

Pre-market Notification Details

Device IDK132829
510k NumberK132829
Device Name:QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne,  NJ  07470
ContactWhitney Torning
CorrespondentWhitney Torning
MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne,  NJ  07470
Product CodeDTZ  
Subsequent Product CodeDTM
Subsequent Product CodeDTR
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-09-09
Decision Date2013-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04037691843353 K132829 000
04058863299983 K132829 000
04037691870304 K132829 000
04037691452982 K132829 000
04037691670171 K132829 000
04037691725079 K132829 000
04037691727868 K132829 000
04037691739335 K132829 000
04037691741161 K132829 000
04037691770987 K132829 000
04037691780481 K132829 000
04037691782089 K132829 000
04037691873060 K132829 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.