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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal, Long-Term Indwelling
510(k) Number K213602
Device Name Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Applicant
Covidien, LLC
15 Hampshore St.
Mansfield,  MA  02048
Applicant Contact Carol S Ming
Correspondent
Covidien, LLC
15 Hampshore St.
Mansfield,  MA  02048
Correspondent Contact Carol S Ming
Regulation Number876.5630
Classification Product Code
FJS  
Date Received11/15/2021
Decision Date 01/14/2022
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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