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

    VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER

    K Number: K010485 · Decision May 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    1
    Review Days
    87

    Basic Information

    Device Name
    VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
    K Number
    K010485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B BRAUN
    Date Received
    February 20, 2001
    Decision Date
    May 18, 2001
    Product Code
    DTK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTK Filter, Intravascular, Cardiovascular

    Similar 510(k) Clearances

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

    Option ELITE Vena Cava Filter System (352506070E 352506100E)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all