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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K242420
Device Name pNOVUS 21 Microcatheter
Applicant
Phenox, Ltd.
Kamrick Court
Ballybrit Business Park
Galway,  IE H91XY38
Applicant Contact Rachel McDaid
Correspondent
Phenox, Ltd.
Kamrick Court
Ballybrit Business Park
Galway,  IE H91XY38
Correspondent Contact Rachel McDaid
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
QJP  
Date Received08/15/2024
Decision Date 11/12/2024
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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