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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K253469
Device Name Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)
Applicant
Mozarc Medical Us, LLC
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Sara Miller
Correspondent
Mozarc Medical
710 Medtronic Pkwy.
Minneapolis,  MN  55432
Correspondent Contact Carol Ming
Regulation Number876.5540
Classification Product Code
FIE  
Date Received10/10/2025
Decision Date 08/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Clinical Trials NCT05927532
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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