Device Dossier
PCTA Guidewire - Fielder XT - Catheter guide wire
Device Dossier for PCTA Guidewire - Fielder XT - 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 cerebral blood vessels.’
Functional description
The guide wire is steered through a guiding catheter into the coronary artery and across a lesion (narrowing or occlusion) within the coronary artery under x-ray fluoroscopy. The wire is then used as a railroad for advancement of a balloon and / or a stent to the site of the lesion. The tapered tip allows tracking of micro-channels in chronic total occlusions and highly stenosed lesions during percutaneous coronary interventions