CAPIOX FLEXIBLE VENOUS RESERVOIR

Reservoir, Blood, 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 Capiox Flexible Venous Reservoir.

Pre-market Notification Details

Device IDK040023
510k NumberK040023
Device Name:CAPIOX FLEXIBLE VENOUS RESERVOIR
ClassificationReservoir, Blood, 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 CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2004-01-07
Decision Date2004-03-01
Summary:summary

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