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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, coude
510(k) Number K222279
Device Name Rusch Intermittent Urethral Catheters
Applicant
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Kelly Breheim
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Kelly Breheim
Regulation Number876.5130
Classification Product Code
EZC  
Date Received07/29/2022
Decision Date 08/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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