Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4600](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4600) → QVQ — Extravascular Support For An Arteriovenous Fistula For Vascular Access

# QVQ · Extravascular Support For An Arteriovenous Fistula For Vascular Access

_Cardiovascular · 21 CFR 870.4600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QVQ

## Overview

- **Product Code:** QVQ
- **Device Name:** Extravascular Support For An Arteriovenous Fistula For Vascular Access
- **Regulation:** [21 CFR 870.4600](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4600)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes

## Identification

Extravascular support for an arteriovenous fistula for vascular access. 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 Rationale

Class II (special controls). The device is granted under the De Novo process, and the probable benefits outweigh the probable risks, which can be mitigated by a robust postmarket surveillance study and the use of general controls and the identified special controls.

## Special Controls

In combination with the general controls of the FD&C Act, the extravascular support for an arteriovenous fistula for vascular access is subject to the following special controls:

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240119](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QVQ/K240119.md) | VasQ | Laminate Medical Technologies , Ltd. | Feb 16, 2024 | SESE |
| [DEN220026](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QVQ/DEN220026.md) | VasQ | Laminate Medical Technologies , Ltd. | Sep 26, 2023 | DENG |

## Top Applicants

- Laminate Medical Technologies , Ltd. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QVQ](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QVQ)

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