Device Dossier

SUOH 03 PTCA Guide Wires - Catheter guide wire

Device Dossier for SUOH 03 PTCA Guide Wires - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Bio-Excel). ARTG…

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

This PTCA Guide Wire is partly radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy during percutaneous transluminal coronary angioplasty procedures.

TGA Public Summary