Device Dossier
ASAHI Gaia PTCA Guidewire - Catheter guide wire
Device Dossier for ASAHI Gaia PTCA Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Bio-Excel).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature
Functional description
The guide wire has a coil-type distal end or a plastic covered-type distal end. The spring coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire’s distal end by fluoroscopy. The guide wire surface has a slip coat coating and the tip is pre-shaped to increase tip shape retention.