Device Dossier
Stingray Guidewire - Catheter guide wire
Device Dossier for Stingray 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
The Stingray Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA). Stingray Guidewires are not to be used in cerebral blood vessels. When used as part of the system consisting of the CrossBoss Catheter, Stingray Catheter, and Stingray Guidewire, the Stingray Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
Functional description
The guidewires have a coiled end where the coil is radiopaque to facilitate advancement into and withdrawal from the vasculature using fluoroscopy. The proximal shaft is coated with PTFE while the distal shaft in the region of the coil is coated with silicone or hydrophilic coating. The narrowed distal tip is intended to aid in guidewire control.