Optilume BPH Catheter System

FDA UDI

Class III (US FDA UDI)

by Urotronic, Inc.

Identity

Trade Name: Optilume BPH Catheter System FDA UDI
Generic Name: Urethral dilatation catheter, drug-eluting FDA UDI
Device Name: The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body. FDA UDI
Model / Reference: 1189 FDA UDI
Description: The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body. FDA UDI

Identifiers

Catalog Number: 1189-30035 FDA UDI
Primary DI / UDI-DI: 00853095008235 FDA UDI
PMA Number: P220029 FDA UDI
FDA Product Code: QXB FDA UDI
GMDN Term: Urethral dilatation catheter, drug-eluting FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Balloon Diameter — 30 Millimeter FDA UDI
Balloon Length — 35 Millimeter FDA UDI
Balloon Rated Burst Pressure — 4 Atmosphere FDA UDI

Category: Urethral dilatation catheter, drug-eluting

Optilume BPH Catheter System by Urotronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral dilatation catheter, drug-eluting.

Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc. · Class III
Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc. · Class III
Optilume BPH Catheter System — Urotronic, Inc. · Class III
Optilume Urethral Drug Coated Balloon — Urotronic, Inc. · Class III
Optilume Urethral Drug Coated Balloon — Urotronic, Inc. · Class III
Optilume Urethral Drug Coated Balloon — Urotronic, Inc. · Class III
Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc. · Class III
Optilume Urethral Drug Coated Balloon — Urotronic, Inc. · Class III

Cleared under the same submission

P220029 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Urotronic, Inc.

Sources (1)

FDA UDI 5c5f6134-0efc-4907-96f0-865c6347859d 38 fields · synced Jun 1, 2026