510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN220026Unknown

VasQ

Laminate Medical Technologies, Tel Aviv, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN220026 is the FDA 510(k) clearance record for VasQ, a class II device, cleared for Laminate Medical Technologies , Ltd. on under FDA product code QVQ (Extravascular Support For An Arteriovenous Fistula For Vascular Access). FDA's definition for product code QVQ reads: "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". FDA records list 2 510(k) clearances for Laminate Medical Technologies , Ltd., from to . As of , FDA records show no recalls naming DEN220026.

Clearance record

Decision date
Received
(515 days to decision)
Product code
QVQ Extravascular Support For An Arteriovenous Fistula For Vascular Access
Regulation
21 CFR 870.4600
Device class
Class II
Review panel
Cardiovascular
Applicant
Laminate Medical Technologies , Ltd. 24 Raoul Wallenberg St., Tel Aviv, IL
Third party review
No

Clearances, product code QVQ

Trailing 12 months

FDA records hold no clearances under product code QVQ in the trailing twelve months.

FDA records show no clearances under product code QVQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260