Device Dossier
Broadway 8 Aspiration Catheter - Catheter, intravascular, guiding
Device Dossier for Broadway 8 Aspiration Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Stryker). ARTG…
- GMDN category: Catheter, intravascular, guiding
- Sponsor: Stryker
Intended purpose
The Broadway 8 Aspiration Catheter is intended to facilitate the insertion and guidance of appropriately sized interventional devices into a selected blood vessel. The Broadway 8 Aspiration Catheter is also intended to remove/aspirate soft emboli and thrombi from vessels.
Functional description
The Broadway 8 Aspiration Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The catheter shaft has a lubricious hydrophilic coating at the distal end (distal 34 cm) to reduce friction during use. It is packaged with two Rotating Hemostatic Valves, two peel-away introducer sheaths and one FastPass Delivery Assist Catheter.