# Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
> **Product code: PQK** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1252
## Classification
- **FDA Product Code:** PQK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.1252
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PQK)
---
*AI Analytics · CC0 1.0*