Aspiration Catheters
Export Aspiration Catheter
Indications for Use
The Export Aspiration Catheter is indicated for use with the Guardwire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:
0 Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
0 To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
0 The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
0 Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
0 To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
0 The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
Key Specifications
- Dual lumen catheter
- Main continuous lumen for aspiration/infusion
- Smaller guidewire lumen sized for 0.14-inch wire
- Guidewire lumen designed as single operator lumen, present only on small section of distal end
- Larger aspiration lumen
- Provided with 20cc aspiration syringe
- Provided with aspiration line attached to proximal end for evacuating blood and debris
- Manufactured using same processes and materials as predicate device
Description
The Export Aspiration Catheter is a dual lumen catheter for use with the Guardwire Temporary Occlusion and Aspiration System. The main (continuous) lumen is the aspiration/infusion lumen, while the smaller lumen is the guidewire lumen to run over the Guardwire, sized for a 0.14-inch wire and designed as a single operator lumen present only on a small section of the distal end. The larger lumen is the aspiration lumen, with a 20cc aspiration syringe and aspiration line provided for attachment to the proximal end to facilitate evacuation of blood and debris.