FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

FMD Peripheral Guide Wires are thin wires designed to facilitate the placement and exchange of diagnostic and therapeutic devices during minimally invasive peripheral artery procedures. The device consists of a stainless steel core wire with a platinum-nickel radiopaque coil on the distal end, PTFE coating on the proximal portion, and hydrophilic coating distally to reduce friction.

The subject devices are available in 0.014-inch (F-14) and 0.018-inch (F-18) nominal diameters in lengths of 190-300 cm. Key differences from the predicate include the addition of preshaped distal tip configurations (in addition to straight tips) and introduction of a new color option. All other technological characteristics—materials, coatings, core design, and sterilization method—remain identical to the predicate device.

Testing was performed per FDA's 2019 guidance document 'Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labelling,' and in accordance with EN ISO 14971:2019 for risk management and ISO 11135:2014 for ethylene oxide sterilization validation.

The subject devices are substantially equivalent to the predicate FMD Peripheral Guide Wire F-18 Flex (K212268) because they have identical indications for use, intended use, fundamental materials and manufacturing processes, design principles, operating principles, biocompatibility profile, and sterilization methods. The minor modifications—preshaped tip options and color—do not alter intended use or fundamental operating principles, and all performance testing met acceptance criteria with results similar to the predicate.