CAPIOX ARTERIAL FILTER

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Arterial Filter.

Pre-market Notification Details

Device IDK943917
510k NumberK943917
Device Name:CAPIOX ARTERIAL FILTER
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactSandi Hartka
CorrespondentSandi Hartka
TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-11
Decision Date1995-07-25

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