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510(k) DEN220026

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

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 26, 2023
Date Received
April 29, 2022
Clearance Type
Direct
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.

  • K240119 — VasQ (February 16, 2024)

Other clearances for product code QVQ

  • K240119 — VasQ (February 16, 2024)