Terumo Capiox NX19 Oxygenator With Reservoir (east Orientation ), Terumo Capiox NX19 Oxygenator With Reservoir (west Orientation ), Terumo Capiox NX19 Oxygenator (east Orientation ), Terumo Capiox NX19 Oxygenator (west Orientation)

Oxygenator, 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 Terumo Capiox Nx19 Oxygenator With Reservoir (east Orientation ), Terumo Capiox Nx19 Oxygenator With Reservoir (west Orientation ), Terumo Capiox Nx19 Oxygenator (east Orientation ), Terumo Capiox Nx19 Oxygenator (west Orientation).

Pre-market Notification Details

Device IDK172071
510k NumberK172071
Device Name:Terumo Capiox NX19 Oxygenator With Reservoir (east Orientation ), Terumo Capiox NX19 Oxygenator With Reservoir (west Orientation ), Terumo Capiox NX19 Oxygenator (east Orientation ), Terumo Capiox NX19 Oxygenator (west Orientation)
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton,  MD  21921
ContactGarry A. Courtney
CorrespondentGarry A. Courtney
Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton,  MD  21921
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-10
Decision Date2018-03-29
Summary:summary

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