Extravascular Support For An Arteriovenous Fistula For Vascular Access

QVQ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4600

Classification

FDA Product Code: QVQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.4600
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

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