Balloon, Detachable, For Neurovascular Occlusion
The Detachable Balloon for Neurovascular Occlusion is an interventional neuroradiology device used to occlude blood vessels in the brain or skull base, such as in the treatment of cerebrovascular aneurysms, arteriovenous fistulas, or tumor embolization. The balloon is detached and left in place to permanently occlude the target vessel. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 882.5950 (Neurology specialty). This device carries both implant and life-sustaining support flags due to its permanent intravascular placement.
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Basic Information
- Product Code
- MZQ
- Device Class
- FDA class 2
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.