Temporary Embolization Assist Device, Peripheral

QZU · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3325

Classification

FDA Product Code: QZU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.3325
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.

Market data

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

Source

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