21 CFR 882.5175 — Clamp, Carotid Artery

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5175

Identification

A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the aneurysm or malformation.

Classification Rationale

Class II (performance standards).

Product Codes