APRO 55 Intermediate Catheter

The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter designed to facilitate insertion and guidance of interventional devices into peripheral and neurovascular blood vessels. It features a hydrophilic coating on the distal segment and a radiopaque marker at the tip for fluoroscopic visualization, and is provided with an introducer sheath.

The subject device is identical to the predicate device (K234115) in technology, principle of operation, materials, sterilization method, and performance. The only difference is the packaging configuration: the subject device includes a hoop coil (like the reference device K243297) instead of a packaging tube, and has a 1-year shelf life instead of 6 months.

ISO 11135 (ethylene oxide sterilization and sterility assurance level verification), ISO 10993-1 (biocompatibility evaluation for externally communicating devices with circulating blood contact ≤24 hours), and FDA guidance on Use of International Standard ISO 10993-1.

The device is substantially equivalent because it maintains identical design, materials, processing, and sterilization to the predicate device. The packaging change (hoop coil configuration) does not affect device safety or effectiveness; aging and packaging integrity testing confirmed the new configuration maintains sterility and shelf-life performance. Since materials and biocompatibility are unchanged, no new biocompatibility or clinical testing was required.