FII

System, Dialysate Delivery, Sealed

Product code: FII
Device name: System, Dialysate Delivery, Sealed
Device class: Class 2
21 CFR: 21 CFR 876.5860
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
Flag: Life-sustaining / life-supporting
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

Official FDA classification page: FII

Classification and pathway per current FDA publications. Data from openFDA (CC0).