Device Dossier
ASAHI Gaia Next PCI Guide Wire - Catheter guide wire
Device Dossier for ASAHI Gaia Next PCI Guide Wire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
This guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI). This guidewire is not intended for use in the neurovasculature and peripheral vasculature.
Functional description
The ASAHI Gaia Next PCI Guide Wire is a steerable guide wire used during PCI. It consists of a tapered core wire and two types of distal coils. The tapered core wire and coils are soldered together. The distal end of the guide wire has a radiopaque outer coil and inner coil to achieve visibility under fluoroscopy and can be made to bend easily with the vessel curve.