Connector, Shunt

Device Code: 1884

Product Code(s): FJQ

Device Classification Information

Device Type ID1884
Device NameConnector, Shunt
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 1 Medical Device
Product CodeFJQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1884
DeviceConnector, Shunt
Product CodeFJQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBlood Access Device And Accessories.
CFR Regulation Number876.5540 [🔎]
TPLC Last Update: 2019-04-02 20:01:22

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