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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K212077
Device Name Teleflex Rusch SoftSimplastic Foley Catheters
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Kelley Breheim
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Kelley Breheim
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/02/2021
Decision Date 07/27/2023
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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