QVQ
- 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240119 | 2024-02-16 | Laminate Medical Technologies , Ltd. | VasQ | |
| DEN220026 | 2023-09-26 | Laminate Medical Technologies , Ltd. | VasQ | — |
Official FDA classification page: QVQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).