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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 K190338
FOIA Releasable 510(k) K190338
Device Name 046 Zenith Flex
Applicant
Inneuroco, Inc.
4635 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact Marc Litzenberg
Correspondent
Inneuroco
4635 NW 103rd Ave.
Sunrise,  FL  33351
Correspondent Contact Marianne Grunwaldt
Regulation Number870.1250
Classification Product Code
NRY  
Date Received02/14/2019
Decision Date 08/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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