EUROPHILIC SLIPPERY COATED FOLEY CATHETER

Catheter, Retention Type, Balloon

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Europhilic Slippery Coated Foley Catheter.

Pre-market Notification Details

Device IDK944007
510k NumberK944007
Device Name:EUROPHILIC SLIPPERY COATED FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant BAXTER HEALTHCARE CORP. 27636 AVE SCOTT SUITE B Velencia,  CA  91355
ContactKam H Leung
CorrespondentKam H Leung
BAXTER HEALTHCARE CORP. 27636 AVE SCOTT SUITE B Velencia,  CA  91355
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-16
Decision Date1995-06-29

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