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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K253791
Device Name PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid
Applicant
DePuy Mitek, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Jeffrey Dzialo
Correspondent
DePuy Mitek, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Jeffrey Dzialo
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/28/2025
Decision Date 02/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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