Device Dossier
Luge PTCA Guidewire - Catheter guide wire
Device Dossier for Luge PTCA Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston Scientific).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
Intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. Not intended for use in the cerebral vasculature.
Functional description
The Luge PTCA Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter 0.014" (0.37mm) and in nominal lengths of 182 or 300cm. It is available with a shapeable straight tip or a pre-formed "J" tip.