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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 K213314
Device Name CerusEndo Microcatheter (027)
Applicant
Cerus Endovascular, Inc.
47757 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact Lori Adels
Correspondent
Cerus Endovascular, Ltd.
47757 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact Lori Adels
Regulation Number870.1250
Classification Product Code
QJP  
Date Received10/04/2021
Decision Date 03/15/2022
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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