Device Dossier
Adelante Peel Away Introducer System - Vascular introducer kit
Device Dossier for Adelante Peel Away Introducer System - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor…
- GMDN category: Vascular catheter introduction set, nonimplantable
Intended purpose
The Adelante Peel Away Introducer System is intended for the introduction of pacing leads or catheters into the body. It is sterile and single use.
Functional description
The Adelante Peel Away Introducer System consists of an introducer sheath and a dilator. Some models include accessories: syringe, needle and guidewire (with J shaped distal tip with straightener). The sheath tube has a hydrophobic coating and a tapered tip. The sheath material is manufactured with radiopaque material which allows the visualization under fluoroscopy.