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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 K230400
Device Name Cure Catheter Closed System; Cure Dextra Closed System
Applicant
Convatec, Inc.
7815 National Service Rd.,
Suite 600
Greensboro,  NC  27409
Applicant Contact Courtney Smith
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Dawn Norman
Regulation Number876.5130
Classification Product Code
EZD  
Date Received02/15/2023
Decision Date 11/08/2023
Decision Substantially Equivalent - Kit (SESK)
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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