Urethral Warming Catheter Kit

Unit, Cryosurgical, Accessories

Varian Medical Systems, Inc.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Urethral Warming Catheter Kit.

Pre-market Notification Details

Device IDK211149
510k NumberK211149
Device Name:Urethral Warming Catheter Kit
ClassificationUnit, Cryosurgical, Accessories
Applicant Varian Medical Systems, Inc. 9825 Spectrum Drive, Building 2, Suite 250 Austin,  TX  78717
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems, Inc. 9825 Spectrum Drive, Building 2, Suite 250 Austin,  TX  78717
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-19
Decision Date2022-01-05

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.