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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K191687
Device Name pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Applicant
phenox Limited
Kamrick Court, Ballybrit Business Park
Galway,  IE H91XY38
Applicant Contact Gary Brogan
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
MOF  
Date Received06/24/2019
Decision Date 10/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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