Device typeFemoral artery closure plug/patch, collagen: An implantable, bioabsorbable device designed for haemostasis/closure of a femoral artery access (catheterization) site, through pressure/compression, as an alternative to manual compression or surgical techniques to reduce the time to haemostasis, it may additionally be intended for femoral vein access site closure. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.
FDA categoryDevice, Hemostasis, Vascular
Device IDM729700500DX0
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Safe
Catheter Gauge5 French