HCE — Clamp, Carotid Artery Class II
FDA product code HCE covers "Clamp, Carotid Artery", a Class II medical device regulated under 21 CFR 882.5175. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HCE
- Device Class
- Class II
- Regulation Number
- 882.5175
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes