21 CFR 870.4600 — Extravascular Support For An Arteriovenous Fistula For Vascular Access
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4600
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access | 2 | 2 | Implant |
Special Controls
QVQ — Extravascular Support For An Arteriovenous Fistula For Vascular Access
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:
De Novo Order DEN220026
