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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extravascular Support For An Arteriovenous Fistula For Vascular Access
510(k) Number K263598
Device Name VasQ
Applicant
Laminate Medical Technologies
24 Raoul Wallenberg St.
Tel Aviv,  IL 6971921
Applicant Contact Orit Yarden
Correspondent
Laminate Medical Technologies
24 Raoul Wallenberg St.
Tel Aviv,  IL 6971921
Correspondent Contact Orit Yarden
Classification Product Code
QVQ  
Date Received09/30/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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