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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K152913
Device Name GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
Applicant
Creganna Medical Aslo Business AS Cregganna Tactx Medical
Parkmore W.
Galway,  IE
Applicant Contact ORLA HICKEY
Correspondent
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Correspondent Contact Kaitlin Grove
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/02/2015
Decision Date 07/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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