Urotronic Inc

FDA Filings

This page includes the latest FDA filings for Urotronic Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3015228875
FEI Number3015228875
NameUROTRONIC INC
Owner & OperatorUrotronic Inc
Contact Address2495 Xenium Lane North
Plymouth MN 55441 US
Official Correspondent
  • Brad Andersen
  • x-763-2857480-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2495 Xenium Lane North
Plymouth, MN 55441 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Urotronic, Inc.
Optilume Urethral Drug Coated Balloon2022-02-03
Urotronic, Inc.
Optilume Urethral Drug Coated Balloon2022-01-27
Urotronic, Inc.
Optilume Urethral Drug Coated Balloon2022-01-19
Urotronic, Inc.
Optilume Urethral Drug Coated Balloon2021-12-03
UROTRONIC INC
Optilume Basic Urological Balloon Dilation Catheter2020-03-16
Urotronic Inc
Optilume Basic Urological Balloon Dilation Catheter2020-01-02

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