Optilume Urethral Drug Coated Balloon

FDA UDI

Class III (US FDA UDI)

by Urotronic, Inc.

Identity

Trade Name: Optilume Urethral Drug Coated Balloon FDA UDI
Generic Name: Urethral dilatation catheter, drug-eluting FDA UDI
Device Name: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use. FDA UDI
Model / Reference: 1110 FDA UDI
Description: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use. FDA UDI

Identifiers

Catalog Number: 1110-08030B FDA UDI
Primary DI / UDI-DI: 00853095008327 FDA UDI
PMA Number: P210020 FDA UDI
FDA Product Code: QRH 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

FDA UDI

Combination Product

Yes

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 — 8 Millimeter FDA UDI
Balloon Length — 50 Millimeter FDA UDI
Balloon Rated Burst Pressure — 12 Atmosphere FDA UDI

Category: Urethral dilatation catheter, drug-eluting

Optilume Urethral Drug Coated Balloon 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

P210020 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 5f46fbe2-1fab-4356-a2b5-ae99ba023cfe 37 fields · synced May 30, 2026