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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 K262398
Device Name CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
Applicant
CERENOVUS, Inc.
6303 Waterford District Dr.
Suite 315
Miami,  FL  33126
Applicant Contact Mia Dudicova
Correspondent
CERENOVUS, Inc.
6303 Waterford District Dr.
Suite 315
Miami,  FL  33126
Correspondent Contact Mia Dudicova
Regulation Number870.1250
Classification Product Code
NRY  
Subsequent Product Code
QJP  
Date Received07/14/2026
Decision Date 08/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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