NUF — Catheter, Neurovasculature, Occluding Balloon Class III
FDA product code NUF covers "Catheter, Neurovasculature, Occluding Balloon", a Class III medical device regulated under 21 CFR 882.5150. Submissions are reviewed by the Neurology panel.
Classification Details
- Product Code
- NUF
- Device Class
- Class III
- Regulation Number
- 882.5150
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management