Device Dossier

Numen Coil Embolization System - Neurovascular embolization coil

Device Dossier for Numen Coil Embolization System - Neurovascular embolization coil (Neurovascular embolization coil, Class III, sponsor RQSolutions…

Intended purpose

The Medical Device is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels

Functional description

The Numen Coil Embolization System is composed of two parts, introducer sheath and coil system. The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.

TGA Public Summary