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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 K241221
Device Name CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
Applicant
Cerenovus, Inc.
6303 Waterford District Dr., Suites 215 & 315
Miami,  FL  33126
Applicant Contact Cara Feely
Correspondent
Cerenovus, Inc.
6303 Waterford District Dr., Suites 215 & 315
Miami,  FL  33126
Correspondent Contact Cara Feely
Regulation Number870.1250
Classification Product Code
NRY  
Date Received05/01/2024
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
Predetermined Change
Control Plan Authorized		 No
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