Device Dossier

PV Tracker - Cardiac/peripheral vascular guidewire, single-use

Device Dossier for PV Tracker - Cardiac/peripheral vascular guidewire, single-use (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor…

Intended purpose

To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for percutaneous transluminal coronary angioplasty (PTCA) use.

Functional description

PTFE coated, stainless steel J-tip guidewire packaged in a spiral hoop fitted with a luer hub for flushing prior to use. Includes J-Straightener that aids in the insertion of the guidewire into the interfacing device. Package contains: 1 Guidewire, 1 J-Straightener, 1 Dispenser Hoop and 1 Luer.

TGA Public Summary