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510(k) K240119

VasQ by Laminate Medical Technologies , Ltd. — Product Code QVQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2024
Date Received
January 16, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extravascular Support For An Arteriovenous Fistula For Vascular Access
Device Class
Class II
Regulation Number
870.4600
Review Panel
CV
Submission Type

This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery.

Other clearances by Laminate Medical Technologies , Ltd.

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