Identity
- Trade Name
- Optilume BPH Pre-dilation Catheter FDA UDI
- Generic Name
- Urethral dilatation catheter, non-medicated 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
- 1137 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
- 1137-30035 FDA UDI
- Primary DI / UDI-DI
- 00853095008150 FDA UDI
- PMA Number
- P220029 FDA UDI
- FDA Product Code
- QXB FDA UDI
- GMDN Term
- Urethral dilatation catheter, non-medicated 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 30 Millimeter FDA UDIBalloon Length — 35 Millimeter FDA UDIBalloon Rated Burst Pressure — 4 Atmosphere FDA UDI
Category: Urethral dilatation catheter, non-medicated
Optilume BPH Pre-dilation Catheter by Urotronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urethral dilatation catheter, non-medicated.
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Cleared under the same submission
P220029 also covers:
- Optilume BPH Catheter System — Urotronic, Inc.
- Optilume BPH Catheter System — Urotronic, Inc.
- Optilume BPH Catheter System — Urotronic, Inc.
- Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc.
- Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc.
- Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc.
- Optilume BPH Drug Coated Balloon Catheter — Urotronic, Inc.
- Optilume BPH Pre-dilation Catheter — Urotronic, Inc.
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 93da44da-9d69-41a4-99a9-d4d0c61a1c4f 38 fields · synced May 30, 2026