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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
510(k) Number K182487
Device Name CerusEndo Microcatheter
Applicant
Cerus Endovascular, Inc.
47757 Fremont Boulevard
fremont,  CA  94538
Applicant Contact theresa brandner
Correspondent
Cerus Endovascular, Inc.
47757 Fremont Boulevard
fremont,  CA  94538
Correspondent Contact theresa brandner
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/11/2018
Decision Date 07/20/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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