PAX — Surgical Kit Class f
FDA product code PAX covers "Surgical Kit", a Class f medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PAX
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- No
Definition
For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.