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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K180919
Device Name GORE Tri-Lumen Catheter
Applicant
W. L. Gore and Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86005
Applicant Contact Michael Ivey
Correspondent
W. L. Gore and Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86005
Correspondent Contact Michael Ivey
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/09/2018
Decision Date 10/05/2018
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
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