Set, Dialysis, Single Needle (co-axial Flow)

Device Code: 1982

Product Code(s): LBW

Device Classification Information

Device Type ID1982
Device NameSet, Dialysis, Single Needle (co-axial Flow)
Regulation DescriptionBlood Access Device 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 Number876.5540 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeLBW
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1982
DeviceSet, Dialysis, Single Needle (co-axial Flow)
Product CodeLBW
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionBlood Access Device And Accessories.
CFR Regulation Number876.5540 [🔎]
TPLC Last Update: 2019-04-02 20:03:20

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