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

    SAFEFLO VENA CAVA FILTER

    K Number: K081138 · Decision May 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    1
    Review Days
    381

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SAFEFLO VENA CAVA FILTER
    K Number
    K081138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Rmt Medical Technilogies, Inc.
    Date Received
    April 21, 2008
    Decision Date
    May 7, 2009
    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