CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING

Oxygenator, 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 Sx10 Hollow Fiber Oxygenator With/without Hardshell Reservoir With X-coating.

Pre-market Notification Details

Device IDK010443
510k NumberK010443
Device Name:CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
ClassificationOxygenator, 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 CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-14
Decision Date2001-12-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.