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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 K211476
Device Name ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
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 Received05/12/2021
Decision Date 06/08/2021
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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