ADAPTERS WITH X-COATING

Adaptor, Stopcock, Manifold, Fitting, 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 Adapters With X-coating.

Pre-market Notification Details

Device IDK022918
510k NumberK022918
Device Name:ADAPTERS WITH X-COATING
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton,  MD  21921
ContactKazuhito Inoue
CorrespondentKazuhito Inoue
Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-04
Decision Date2002-11-27
Summary:summary

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