FDA.reportPublic FDA data

Optilume BPH Drug Coated Balloon Catheter

Primary DI
00853095008402
Brand
Optilume BPH Drug Coated Balloon Catheter
Company
Urotronic, Inc.
Model
1113
Catalog number
1113-30030
Device 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.
Published
2023-08-05
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
QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic HyperplasiaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220029000Optilume™ BPH Catheter SystemUrotronic, Inc.2023-06-30QXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853095008402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853095008402008530950084028530950084020853095008402

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 Diameter30Millimeter
Balloon Length30Millimeter
Balloon Rated Burst Pressure4Atmosphere

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
00853095008129Optilume BPH Drug Coated Balloon CatheterUrotronic, Inc.QXB2023-08-05
00853095008150Optilume BPH Pre-dilation CatheterUrotronic, Inc.QXB2023-08-05
00853095008174Optilume BPH Drug Coated Balloon CatheterUrotronic, Inc.QXB2023-08-05
00853095008181Optilume BPH Catheter SystemUrotronic, Inc.QXB2023-08-05
00853095008235Optilume BPH Catheter SystemUrotronic, Inc.QXB2023-08-05
00853095008426Optilume BPH Pre-dilation CatheterUrotronic, Inc.QXB2023-08-05
00853095008532Optilume BPH Drug Coated Balloon CatheterUrotronic, Inc.QXB2023-08-05
00853095008822Optilume BPH Catheter SystemUrotronic, Inc.QXB2023-08-05
00853095008853Optilume BPH Catheter SystemUrotronic, Inc.QXB2023-08-05