Advanced Perfusion System 1

Console, Heart-lung Machine, Cardiopulmonary Bypass

Terumo Cardiovascular Systems Corporation

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Advanced Perfusion System 1.

Pre-market Notification Details

Device IDK153376
510k NumberK153376
Device Name:Advanced Perfusion System 1
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor,  MI  48103
ContactBryan Hann
CorrespondentBryan Hann
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor,  MI  48103
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-23
Decision Date2015-12-16
Summary:summary

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