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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K253842
Device Name Vena MicroAngioscope™ System
Applicant
Vena Medical Holdings Corp
809 Wellington St.
Unit 2
Kitchener,  CA N2H 5L6
Applicant Contact Joseph De Croos
Correspondent
Vena Medical Holdings Corp
809 Wellington St.
Unit 2
Kitchener,  CA N2H 5L6
Correspondent Contact Joseph De Croos
Date Received12/02/2025
Decision Date 01/28/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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