QVQ

Extravascular Support For An Arteriovenous Fistula For Vascular Access

Product code
QVQ
Device name
Extravascular Support For An Arteriovenous Fistula For Vascular Access
Device class
Class 2
21 CFR
21 CFR 870.4600
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-02-16.

NumberDecision dateApplicantDevice nameSummary
K2401192024-02-16Laminate Medical Technologies , Ltd.VasQPDF
DEN2200262023-09-26Laminate Medical Technologies , Ltd.VasQ

1 summaries are archived here for direct download.

Official FDA classification page: QVQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).