External Cerebrospinal Fluid (Csf) Diversion
The External Cerebrospinal Fluid (CSF) Diversion device is a neurology device intended to alter spinal cord perfusion by diverting cerebrospinal fluid externally, typically used in the setting of aortic surgery to reduce the risk of spinal cord ischemia. It falls under the Neurology medical specialty and is classified as a Class 2 device under regulation 882.5560, requiring 510(k) premarket notification. General controls and special controls apply. It is not an implant and is not life-sustaining.
Research product code PCB in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PCB
- Device Class
- FDA class 2
- Regulation Number
- 882.5560
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.