HCE · Clamp, Carotid Artery
Neurology · 21 CFR 882.5175 · Class 2
Overview
| Product Code | HCE |
|---|---|
| Device Name | Clamp, Carotid Artery |
| Regulation | 21 CFR 882.5175 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870399 | SELVERSTONE CLAMP SALIBI CLAMP | Codman & Shurtleff, Inc. | Mar 6, 1987 | SESE |
| K811821 | CAROTID ARTERY CLAMP & TOOLS | New England Surgical Instrument Corp. | Sep 24, 1981 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 1 clearance
- New England Surgical Instrument Corp. — 1 clearance
