Ring, Crimp

Device Code: 1889

Product Code(s): FJX

Device Classification Information

Device Type ID1889
Device NameRing, Crimp
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) Exempt
CFR Regulation Number876.5540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFJX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1889
DeviceRing, Crimp
Product CodeFJX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBlood Access Device And Accessories.
CFR Regulation Number876.5540 [🔎]
TPLC Last Update: 2019-04-02 20:01:29

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