PTFE Guidewire

The PTFE Guidewire is a single-use catheter guidewire designed to facilitate placement of devices during diagnostic and interventional medical procedures. It is 0.032 inches in diameter and 200 cm long, composed of a 304 stainless steel core and coil with a low-friction polytetrafluoroethylene (PTFE) coating, and is sterilized using ethylene oxide. The device is explicitly not intended for percutaneous transluminal coronary angioplasty (PTCA) use.

The PTFE Guidewire has identical functional characteristics to its predicate device (Cardiovascular and Vascular Guidewire, K935170) regarding material composition (304 stainless steel core and coil with PTFE coating), dimensions (0.032 inches diameter, 200 cm length), and construction method (core and coil welded at distal and proximal ends). Both are general-use guidewires with the same indications for use.

Testing referenced FDA guidance for coronary, peripheral, and neurovascular guidewires (October 2019), ISO 10993-1 (biocompatibility), EN ISO 11070:2014/A1:2018 (guidewire performance), EN ISO 10555-1:2023 (corrosion resistance), ASTM standards (F88/F88M-23, F1929-23, F2096-11, F1980-21, D4169023), USP 788 (particulate residue), and ISTA 3A (packaging integrity).

Substantial equivalence is based on identical indications for use, principles of operation, and functional characteristics between the subject device and predicate. Both are general-use guidewires for diagnostic and interventional procedures with the same material composition, dimensions, and manufacturing method. Comprehensive bench testing demonstrated the subject device meets all predetermined acceptance criteria across 23 performance and safety parameters using the same standards and acceptance criteria as the predicate device, with no new questions of safety or effectiveness raised.