Clamp, Cannula

Device Code: 1894

Product Code(s): FKC

Device Classification Information

Device Type ID1894
Device NameClamp, Cannula
Regulation DescriptionBlood Access Device And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(K) Exempt
CFR Regulation Number876.5540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFKC
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1894
DeviceClamp, Cannula
Product CodeFKC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBlood Access Device And Accessories.
CFR Regulation Number876.5540 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
2
Leak / Splash
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:01:33

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