Peripheral Temporary And Retrievable Stent System

SEU · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5110

Classification

FDA Product Code: SEU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.5110
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 5

Source

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