21 CFR 882.5150 — Catheter, Intravascular Occluding

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5150

Identification

An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

Classification Rationale

Class III (premarket approval).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HBZCatheter, Intravascular Occluding30
NUFCatheter, Neurovasculature, Occluding Balloon30Life-Sustaining
PAVCatheter, Neuro-Vasculature, Occluding Balloonf0
Innolitics

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