System, Dialysate Delivery, Semi-automatic, Peritoneal

Device Code: 1969

Product Code(s): KPF

Device Classification Information

Device Type ID1969
Device NameSystem, Dialysate Delivery, Semi-automatic, Peritoneal
Regulation DescriptionPeritoneal Dialysis System And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type510(k)
CFR Regulation Number876.5630 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKPF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1969
DeviceSystem, Dialysate Delivery, Semi-automatic, Peritoneal
Product CodeKPF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPeritoneal Dialysis System And Accessories.
CFR Regulation Number876.5630 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
4
Total Device Problems 4
TPLC Last Update: 2019-04-02 20:03:02

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