CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR

Oxygenator, Cardiopulmonary Bypass

ASHITAKA FACTORY OF TERUMO CORP.

The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corp. with the FDA for Capiox Fx15 And Fx25 Hollow Fiber Oxygenator/reservoir.

Pre-market Notification Details

Device IDK130520
510k NumberK130520
Device Name:CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya, Shizuoka,  JP 418-0015
ContactEileen Dorsey
CorrespondentEileen Dorsey
ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya, Shizuoka,  JP 418-0015
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-02-28
Decision Date2013-03-13
Summary:summary

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