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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K242672
Device Name Zoom System
Applicant
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Teri Nguyen
Correspondent
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Teri Nguyen
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/06/2024
Decision Date 01/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04129125
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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