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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 K261176
Device Name Zoom 4S Catheter
Applicant
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Peter Taylor
Correspondent
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Peter Taylor
Regulation Number870.1250
Classification Product Code
QJP  
Date Received04/10/2026
Decision Date 08/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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