Temporary Coil Embolization Assist Device

PUU · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5955

Classification

FDA Product Code: PUU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5955
Review panel: NE
Medical specialty: Neurology
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 neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature 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