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FDA 510(k) Applications Submitted by KRISTIN ELLIS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210996
04/02/2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Imperative Care Inc.
K212224
07/16/2021
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Imperative Care Inc.
K153485
12/03/2015
ENROUTE Transcarotid Neuroprotection System
SILK ROAD MEDICAL, INC.
K203764
12/23/2020
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Imperative Care Inc.
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