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Optilume Urethral Drug Coated Balloon Catheter Kit

Urotronic, Inc. · Model 1230 · UDI-DI 00859937006285

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Description

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.