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August 5, 2020
FDA Clears Surmodics’ Sublime Radial Access 0.014 RX PTA Dilatation Catheter for BTK Treatment
August 5, 2020—Surmodics, Inc. announced it has received FDA 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous transluminal angioplasty (PTA) dilatation catheter. The device allows below-the-knee access through a transradial approach by providing a working length of 250 cm. Outer balloon diameters range from 2 to 4 mm with balloon lengths between 20 and 220 mm.
According to Surmodics, the Sublime 0.014 RX PTA dilatation catheter is compatible with a 5-F guide sheath. The device is designed to provide the performance of an over-the-wire PTA catheter in an RX platform. A reinforced shaft technology with flexible, kink-resistant construction and a tapered RX port transition provides optimal trackability and push-through distal tortuosity.
The product joins Surmodics’ previously cleared Sublime radial guide sheath within the company’s Sublime radial access platform and is designed to facilitate radial access for the treatment of above- or below-the-knee arteries.
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