System, Blood, Extracorporeal And Accessories
System, Blood, Extracorporeal and Accessories is a system in which blood is removed from the patient, processed outside the body (extracorporeally), and returned, used in procedures such as hemodialysis, hemofiltration, or plasmapheresis for the treatment of renal failure or removal of toxins and harmful substances from the blood. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLB, regulated under 21 CFR 876.5820, within the Gastroenterology/Urology medical specialty. This device is life sustaining or life supporting.
Research product code LLB 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
- LLB
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- 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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.