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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 K241244
Device Name CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
Applicant
Cerenovus, Inc.
6303 Waterford District Drive 215 & 315
Miami,  FL  33126
Applicant Contact Cara Feely
Correspondent
Cerenovus, Inc.
6303 Waterford District Drive 215 & 315
Miami,  FL  33126
Correspondent Contact Cara Feely
Regulation Number870.1250
Classification Product Code
QJP  
Date Received05/02/2024
Decision Date 10/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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