Venous Window Needle Guide

PFH · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5540

Classification

FDA Product Code: PFH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5540
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

Definition

For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown