UROTRONIC INC

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• laborie.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Optilume Urethral Drug Coated Balloon

  2022-09-29

  Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS006 Date Received08/30/2022 Decision Date09/29/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supple...

• Optilume Urethral Drug Coated Balloon

  2022-06-10

  Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS005 Date Received05/12/2022 Decision Date06/10/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supple...

• Optilume Urethral Drug Coated Balloon

  2022-05-17

  Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS004 Date Received02/24/2022 Decision Date05/17/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Pro...

• Optilume Urethral Drug Coated Balloon

  2022-02-03

  Urotronic, Inc.

• Optilume Urethral Drug Coated Balloon

  2022-01-27

  Urotronic, Inc.

• Optilume Urethral Drug Coated Balloon

  2022-01-19

  Urotronic, Inc.

• Optilume Urethral Drug Coated Balloon

  2021-12-03

  Urotronic, Inc.

PMN#

• Optilume Basic Urological Balloon Dilation Catheter

  2020-01-02

  Urotronic Inc

GUDID#

• Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral Drug Coated Balloon catheter, one Optilume Basic Urological Dilahttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#tion catheter and an Atrion Medical Inflation device. 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. The Optilume® Basic catheter is the same catheter as the Optilume® Urethral DCB without the drug coating. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral Drug Coated Balloon catheter, one Optilume Basic Urological Dilation catheter and an Atrion Medical Inflation device. 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. The Optilume® Basic catheter is the same catheter as the Optilume® Urethral DCB without the drug coating. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral Drug Coated Balloon catheter, one Optilume Basic Urological Dilation catheter and an Atrion Medical Inflation device. 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. The Optilume® Basic catheter is the same catheter as the Optilume® Urethral DCB without the drug coating. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral Drug Coated Balloon catheter, one Optilume Basic Urological Dilation catheter and an Atrion Medical Inflation device. 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. The Optilume® Basic catheter is the same catheter as the Optilume® Urethral DCB without the drug coating. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Urethral Drug Coated Balloon Catheter Kit - Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon catheter and an Atrion Medical Inflation device. 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. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

  Urotronic, Inc.

  2026-02-09

• Optilume Basic Urological Dilation catheter - The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

  Urotronic, Inc.

  2025-07-18

• Optilume Basic Urological Dilation catheter - The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

  Urotronic, Inc.

  2025-07-18

• Optilume Basic Urological Dilation catheter - The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

  Urotronic, Inc.

  2025-07-18

• Optilume Basic Urological Dilation catheter - The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

  Urotronic, Inc.

  2025-07-18

• Optilume Basic Urological Dilation catheter - The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

  Urotronic, Inc.

  2025-07-18

• Optilume Basic Urological Dilation catheter - The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

  Urotronic, Inc.

  2025-07-18

• Optilume BPH Drug Coated Balloon Catheter - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Pre-dilation Catheter - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Drug Coated Balloon Catheter - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Catheter System - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Catheter System - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Drug Coated Balloon Catheter - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Pre-dilation Catheter - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Drug Coated Balloon Catheter - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Catheter System - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume BPH Catheter System - 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.

  Urotronic, Inc.

  2023-08-05

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04

• Optilume Urethral Drug Coated Balloon - 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.

  Urotronic, Inc.

  2022-12-04