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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 K231168
FOIA Releasable 510(k) K231168
Device Name TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Applicant
Imperative Care Inc.
1359 Dell Avenue
Campbell,  CA  95008
Applicant Contact Shivani Patel
Correspondent
Imperative Care Inc.
1359 Dell Avenue
Campbell,  CA  95008
Correspondent Contact Shivani Patel
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received04/25/2023
Decision Date 05/22/2023
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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