TERUMO HOLLOW FIBER OXYGENATOR

Oxygenator, Cardiopulmonary Bypass

TERUMO AMERICA, INC.

The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Terumo Hollow Fiber Oxygenator.

Pre-market Notification Details

Device IDK802970
510k NumberK802970
Device Name:TERUMO HOLLOW FIBER OXYGENATOR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-21
Decision Date1981-01-22

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