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LLB — System, Blood, Extracorporeal And Accessories Class II

FDA Device Classification

FDA product code LLB covers "System, Blood, Extracorporeal And Accessories", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LLB
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K991005dayspring medicalVENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC10June 22, 1999
K831404gambroBLOOD MONITOR BMM 10-4April 25, 1984

FDA data resources