Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

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

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