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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 K211120
Device Name ERIC Retrieval Device
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Stephanie Onstot
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Correspondent Contact Sapna Singh
Regulation Number870.1250
Classification Product Code
NRY  
Date Received04/15/2021
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03776877
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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