Device Dossier
Amplatzer™ TorqVue™ Delivery System - Cardiac occluder delivery kit
Device Dossier for Amplatzer™ TorqVue™ Delivery System - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Abbott…
- GMDN category: Cardiac occluder delivery kit
Intended purpose
The Amplatzer™ TorqVue™ Delivery System is intended to facilitate the attachment, loading, delivery and deployment of occluders.The Amplatzer™ TorqVue™ Delivery system is indicated to facilitate the delivery of an occluder into the heart of patients with heart defects.
Functional description
Amplatzer™ TorqVue™ Delivery System is a sterile, single-use device designed to deliver transcatheter devices to specific anatomical locations in cardiovascular system. The procedure involves inserting and locking the dilator into a sheath, advancing the sheath/dilator assembly over an intravascular guidewire, and then connecting a hemostasis valve. An Occluder is attached to the distal end of the delivery cable, retracted into the loader, and then moved through the sheath to the treatment site.