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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 K243047
Device Name Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Applicant
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Michael Wong
Correspondent
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Michael Wong
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/27/2024
Decision Date 05/28/2025
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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