Optilume Basic Urological Balloon Dilation Catheter

Dilator, Urethral

Urotronic Inc

The following data is part of a premarket notification filed by Urotronic Inc with the FDA for Optilume Basic Urological Balloon Dilation Catheter.

Pre-market Notification Details

Device IDK191061
510k NumberK191061
Device Name:Optilume Basic Urological Balloon Dilation Catheter
ClassificationDilator, Urethral
Applicant Urotronic Inc 2495 Xenium Lane N Minneapolis,  MN  55441
ContactDavid Perry
CorrespondentMing Cheng Chew
Libra Medical 8401 73rd Ave N. Suite 63 Minneapolis,  MN  55428
Product CodeKOE  
CFR Regulation Number876.5520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-22
Decision Date2020-01-02

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