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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 K221279
Device Name pNOVUS 21 Microcatheter
Applicant
phenox Ltd
Kamrick Court, Ballybrit Business Park
Galway,  IE H91 XY38
Applicant Contact Sarah Cregg
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
QJP  
Date Received05/03/2022
Decision Date 11/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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