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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, Neurovasculature
510(k) Number K230726
Device Name CEREGLIDE 92 Intermediate Catheter
Applicant
Cerenovus, Inc.
6303 Waterford District Dr.215 & 315
Miami,  FL  33126
Applicant Contact Ryan Rivera
Correspondent
Cerenovus, Inc.
6303 Waterford District Dr.215 & 315
Miami,  FL  33126
Correspondent Contact Ariell Joiner
Regulation Number870.1250
Classification Product Code
QJP  
Date Received03/16/2023
Decision Date 11/29/2023
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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