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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K253807
Device Name Valence InVent Xtend™ (CVG-4101-VXA)
Applicant
Convergence Medical Sciences , Ltd.
4121 23b St. NE
Calgary,  CA T2E 7V9
Applicant Contact Marvin Cervantes
Correspondent
Convergence Medical Sciences , Ltd.
4121 23b St. NE
Calgary,  CA T2E 7V9
Correspondent Contact Marvin Cervantes
Regulation Number868.5895
Classification Product Code
MOD  
Date Received11/28/2025
Decision Date 08/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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