Device Dossier
Dilator, vascular
Device Dossier for Dilator, vascular (Dilator, vascular, Class IIa, sponsor LivaNova). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Dilator, vascular
Intended purpose
The Sorin Vascular Dilator Kit consists of a scalpel, insertion needle, guidewire, and a set of 5 dilators (8, 12, 16, 20, and 24 French). The kit is intended for use in dilating a vessel to aid in introduction of a catheter or cannula. The kit is packaged sterile and intended for single use.