Extension tube

The Extension tube is a single-use, sterile medical device intended as a connecting line for injection of contrast media and saline during coronary angiography procedures. It consists of male/female luer connectors, caps, tubing, and optional components such as Y-type needle access adapters and rotating connectors, rated for pressures up to 1200 psi.

The proposed device offers multiple model configurations with lengths ranging from 23 cm to 404 cm and inner diameters from 1.5 to 2.5 mm, compared to the predicate's single 10–350 cm length and 1.8 mm inner diameter. Both devices use the same conical fitting (ISO 80369-7), EO sterilization method, and biocompatibility standards (ISO 10993 series). The proposed device features additional component options (Y-type needle access adapter, beveled trocar assembly) and a longer shelf-life of 5 years versus 3 years for the predicate.

ISO 8536-4, 8536-9, 8536-10, 8536-12; ISO 80369-7; ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11, 10993-23; ISO 10555-1:2023; ISO 11135-2014; ASTM F756-17, F88, F1886, F1929, F1980; USP <788>; AAMI ANSI CN27:2021.

The Extension tube is substantially equivalent to the predicate High Pressure Tubing (K244038) because both share the same indications for use, regulatory class (Class II, 21 CFR 870.1650), product code (DXT), sterilization method (EO), and design principles. Non-clinical bench and biocompatibility testing demonstrate that differences in component configuration, tubing dimensions, and shelf-life do not raise new safety or effectiveness concerns and do not introduce new risks.