Percutaneous Introducer Kit

Device Code: 2777

Product Code(s): PXB

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.

Device Classification Information

Device Type ID2777
Device NamePercutaneous Introducer Kit
Physical StateThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
Technical MethodThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
Target AreaThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
Regulation DescriptionHypodermic Single Lumen Needle.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission TypeEnforcement Discretion
CFR Regulation Number880.5570 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePXB
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2777
DevicePercutaneous Introducer Kit
Product CodePXB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHypodermic Single Lumen Needle.
CFR Regulation Number880.5570 [🔎]
TPLC Last Update: 2019-04-02 20:18:39

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