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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K261418
Device Name Liquick X-treme, Liquick X-treme Plus
Applicant
Teleflex Medical
Ida Business & Technology Park
Garrycastle, Dublin Rd.
Athlone,  IE
Applicant Contact Aisling Foley
Correspondent
Teleflex Medical
Ida Business & Technology Park
Garrycastle, Dublin Rd.
Athlone,  IE
Correspondent Contact Aisling Foley
Regulation Number876.5130
Classification Product Code
EZD  
Date Received04/30/2026
Decision Date 09/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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