Device Dossier

Hornet™ Guidewire – Straight Tip - Catheter guide wire

Device Dossier for Hornet™ Guidewire – Straight Tip - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston…

Intended purpose

Boston Scientific Hornet Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.

Functional description

Hornet Guidewires with hydrophilic coating are steerable guidewires with a nominal diameter of ≤0.37mm & nominal lengths of 190cm or 300cm. Guidewires have a PTFE coating in proximal section; a hydrophilic coating length of 15 cm and a radiopaque length of 3.5 cm. 190cm guidewires have a 2.1cm friction fit extension section for exchange of Over-the-Wire systems by using Stretch Extension Wire. 300cm guidewires allows exchange of devices without the use of an extension wire or exchange system.

TGA Public Summary