Device Dossier
Amplatzer™ Talisman™ Delivery Sheath - Cardiac occluder delivery kit
Device Dossier for Amplatzer™ Talisman™ Delivery Sheath - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Abbott…
- GMDN category: Cardiac occluder delivery kit
Intended purpose
The Amplatzer™ Talisman™ Delivery Sheath is intended to facilitate the delivery and deployment of an Amplatzer™ PFO Occluder for patients recommended for patent foramen ovale closure with an Amplatzer™ PFO Occluder.
Functional description
The Amplatzer™ Talisman™ Delivery Sheath is a single-use sheath that facilitates the delivery and deployment of the Amplatzer™ Talisman PFO Occluder. The sheath and dilator are radiopaque for visibility under fluoroscopy. For added visibility the sheaths also have a platinum/iridium marker band near the distal tip.