CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING

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 Sx Hardshell Reservoir With X-coating.

Pre-market Notification Details

Device IDK002238
510k NumberK002238
Device Name:CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-24
Decision Date2000-08-22

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