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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 K171672
Device Name 065 Zenith, 074 Zenith
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
DQY  
Date Received06/06/2017
Decision Date 10/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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