Product code HCE— Neurology

CAROTID ARTERY CLAMP & TOOLS

Classification name
Clamp, Carotid Artery
Device class
Class 2
Regulation
21 CFR 882.5175
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

Market context for product code HCE

FDA has cleared 2 devices under product code HCE between 1981 and 1987, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HCE

Recent clearances under product code HCE

Data sourced from openFDA. This site is unofficial and independent of the FDA.