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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 K172167
Device Name Zenith Flex System
Applicant
Inneuroco, Inc.
4635 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact Marc Litzenberg
Correspondent
Inneuroco, Inc.
4635 NW 103rd Ave.
Sunrise,  FL  33351
Correspondent Contact Marianne Grunwaldt
Regulation Number870.1250
Classification Product Code
NRY  
Subsequent Product Codes
DTL   DYB  
Date Received07/18/2017
Decision Date 04/19/2018
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
Recalls CDRH Recalls
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