Device Dossier
SafeSheath II - Vascular introducer kit
Device Dossier for SafeSheath II - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor Biotronik). ARTG…
- GMDN category: Vascular catheter introduction set, nonimplantable
Intended purpose
SafeSheath II is intended for the introduction of various types of pacing leads and catheters.
Functional description
It consists of: - a peel away introducer sheath with at proximal end a colour-coded (French size) cap with lubricated haemostatic valve as well as a side port with 3-way stopcock and at distal end a sheath tube with tapered tip and radiopaque material; - an introducer dilator featuring a hub with syringe luer lock adapter and a dilator tube with tapered tip; - accessories including syringe, needle and guidewire (with J shaped distal tip with straightener).