URESIL DILATOR WITH RADIOPAQUE MARKER

Dilator, Vessel, For Percutaneous Catheterization

URESIL CORP.

The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Dilator With Radiopaque Marker.

Pre-market Notification Details

Device IDK980282
510k NumberK980282
Device Name:URESIL DILATOR WITH RADIOPAQUE MARKER
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant URESIL CORP. 5418 W. TOUHY AVE. Skokie,  IL  60077
ContactLev Melinyshyn
CorrespondentLev Melinyshyn
URESIL CORP. 5418 W. TOUHY AVE. Skokie,  IL  60077
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-26
Decision Date1998-04-24

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