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