FDA 510(k), K203764, TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

510(K) Number: K203764
Device Name: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: KXA
Date Received: 12/23/2020
Decision Date: 03/03/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology