www.fdanews.com/articles/200413-medical-ingenuities-radial-artery-occlusion-device-gets-fda-clearance
Medical Ingenuities’ Radial Artery Occlusion Device Gets FDA Clearance
December 11, 2020
The FDA has given Medical Ingenuities 510(k) clearance for its PH Band, a device used to prevent radial artery occlusion.
The device provides real-time feedback to medical personnel monitoring radial artery patency to prevent radial artery occlusion, a vascular complication of transradial catheterization.
The PH Band is used alongside a micro Doppler Probe to achieve patient hemostasis following a minimally invasive cardiac or vascular procedure and assists in reducing occlusion-related complications and nursing staff burdens.