ADAPTERS WITH X-COATING

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

TERUMO CARDIOVASCULAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Adapters With X-coating.

Pre-market Notification Details

Device IDK003604
510k NumberK003604
Device Name:ADAPTERS WITH X-COATING
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactGarry A Courtney
CorrespondentGarry A Courtney
TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-21
Decision Date2001-02-07

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