> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Class 2 for Percutaneous Catheter for Hemodialysis
- URL: https://www.fdaweb.com/class-2-for-percutaneous-catheter-for-hemodialysis/
- Published: 2022-02-18T12:00:00.000Z
- Updated: 2026-09-14T17:33:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151198

*Federal Register* notice: FDA is classifying the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access into medical device Class 2 (special controls). The action follws a TVA Medical de novo classification request for its everlinQ endoAVF System. The agency has identified the device as being a single-use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-18/pdf/2022-03496.pdf?ref=fdaweb.com).