FDA product code QVQ: Extravascular Support For An Arteriovenous Fistula For Vascular Access
QVQ is the FDA product code for extravascular support for an arteriovenous fistula for vascular access. It is a Class II device, regulated under 21 CFR 870.4600 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QVQ, 1 in the last five years. The average 510(k) review took 31 days (median 31); 31 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Extravascular Support For An Arteriovenous Fistula For Vascular Access |
| Device class | Class II |
| Regulation | 21 CFR 870.4600 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QVQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 31 |
Compare with all 510(k) review times · Search every QVQ clearance
Top QVQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laminate Medical Technologies , Ltd. | 1 | 2024-02-16 |
Most recent QVQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240119 | Laminate Medical Technologies , Ltd. | VasQ | 2024-02-16 | 31 |
Recalls for QVQ devices
openFDA lists no recalls for product code QVQ.
Frequently asked questions
What is FDA product code QVQ?
QVQ is the FDA product code for extravascular support for an arteriovenous fistula for vascular access. It is a Class II device, regulated under 21 CFR 870.4600 and reviewed by the Cardiovascular panel.
What device class is QVQ?
Class II, regulation 21 CFR 870.4600. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVQ?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most QVQ clearances?
Laminate Medical Technologies , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVQ
- Run a recall and safety report across every QVQ manufacturer
- Watch product code QVQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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