Dilation Balloon Catheter

The Dilation Balloon Catheter is a sterile, single-use endoscopic device indicated for use in adults to endoscopically dilate strictures of the biliary tract. The device reaches the target position through the endoscopic channel, inflates to the rated pressure to dilate the stenosis, and is then withdrawn from the body.

The proposed device incorporates the same principle of operation, packaging, fundamental technology, and sterilization as the predicate device. Material, chemical composition, intended use, and configuration are similar, with minor differences that do not affect substantial equivalence. The device has 9 specifications covering balloon length and diameter.

ISO 10993-1 for biocompatibility evaluation; ASTM F1980 for accelerated aging of sterile barrier systems; ISO 11135 for sterilization validation using ethylene oxide.

The proposed device is substantially equivalent to the predicate Reliant(TM) Multistage Dilatation Balloon Catheter (K180418) because it uses the same operational principle, technology, sterilization method, and materials. Non-clinical performance testing demonstrated the device is as safe, effective, and performs as well as the predicate device.