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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K212224
FOIA Releasable 510(k) K212224
Device Name TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Applicant
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Kristin Ellis
Correspondent
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Kristin Ellis
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received07/16/2021
Decision Date 09/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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