FDA.reportPublic FDA data

Optilume Urethral Drug Coated Balloon

Primary DI
00853095008303
Brand
Optilume Urethral Drug Coated Balloon
Company
Urotronic, Inc.
Model
1110
Catalog number
1110-08050B
Device 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.
Published
2022-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRHCatheter, Balloon, Urethral, Drug-Coated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRHCatheter, Balloon, Urethral, Drug-CoatedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210020000Optilume Urethral Drug Coated BalloonUrotronic, Inc.2021-12-03QRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853095008303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853095008303008530950083038530950083030853095008303

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilatation catheter, drug-elutingA sterile, flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage; it includes a drug (e.g., chemotherapy drug) intended to be eluted in situ. The device is typically designed with an inflatable dilation balloon. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter8Millimeter
Balloon Length50Millimeter
Balloon Rated Burst Pressure12Atmosphere

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763.285.7496optilume@urotronic.com

Regulatory Flags#

DUNS number
080558603
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859937006186Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7008B2026-02-09
00859937006193Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7009B2026-02-09
00859937006209Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7010B2026-02-09
00859937006216Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7011B2026-02-09
00859937006247Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7000B2026-02-09
00859937006254Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7001B2026-02-09
00859937006261Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7002B2026-02-09
00859937006278Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7003B2026-02-09
00859937006285Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7004B2026-02-09
00859937006292Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7005B2026-02-09
00859937006308Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7006B2026-02-09
00859937006315Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7007B2026-02-09
00853095008341Optilume Basic Urological Dilation catheter11471147-080302025-07-18
00853095008358Optilume Basic Urological Dilation catheter11471147-080502025-07-18
00853095008365Optilume Basic Urological Dilation catheter11471147-060302025-07-18
00853095008372Optilume Basic Urological Dilation catheter11471147-060502025-07-18
00853095008389Optilume Basic Urological Dilation catheter11471147-100302025-07-18
00853095008396Optilume Basic Urological Dilation catheter11471147-100502025-07-18
00853095008129Optilume BPH Drug Coated Balloon Catheter11131113-300352023-08-05
00853095008150Optilume BPH Pre-dilation Catheter11371137-300352023-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859937006193Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006209Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006216Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006247Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006254Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006261Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006278Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006285Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006292Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006308Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00859937006315Optilume Urethral Drug Coated Balloon Catheter KitUrotronic, Inc.QRH2026-02-09
00853095008242Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04
00853095008273Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04
00853095008280Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04
00853095008297Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04
00853095008310Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04
00853095008327Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04
00853095008334Optilume Urethral Drug Coated Balloon Urotronic, Inc.QRH2022-12-04