BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)

    K Number: K944511 · Decision Mar 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    212
    Registration Numbers
    213
    Same Product Code
    496
    Applicant Total
    4
    Review Days
    179

    Basic Information

    Device Name
    ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)
    K Number
    K944511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NEOSTAR MEDICAL TECHNOLOGIES, INC.
    Date Received
    September 15, 1994
    Decision Date
    March 13, 1995
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FOZ), ordered by most recent decision date.

    BD Cathena™ Safety IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ruby Intravascular Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by NEOSTAR MEDICAL TECHNOLOGIES, INC.

    K Number Device Name
    K960625 SPREADABLE SHEATH INTRODUCER SET
    K941851 DUAL LUMEN CATHETER (DLC) TRAY
    K944660 ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY