FDA 510(k), K220567, Easi-Vue embolic microspheres System

510(K) Number: K220567
Device Name: Easi-Vue embolic microspheres System
Manufacturer: Brandi Woods
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: KRD
Classification Product Code: KXA
Date Received: 02/28/2022
Decision Date: 09/07/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

451 pages (1,749 of 2,220 original pages are fully redacted)