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

    COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT

    K Number: K081425 · Decision Sep 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    12
    Review Days
    132

    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
    COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
    K Number
    K081425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Vascular, Inc.
    Date Received
    May 21, 2008
    Decision Date
    September 30, 2008
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

    Similar 510(k) Clearances

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

    FLEXI-PORT™ Power Injectable Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

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

    Other Clearances by Cook Vascular, Inc.

    K Number Device Name
    K142301 Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
    K141148 EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
    K110347 DOPPLER MONITOR
    K083482 COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
    K061000 EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
    K032223 COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH
    K023937 COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
    K022649 COOK-SWARTZ DOPPLER FLOW PROBE
    K010128 COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
    K002958 SHAPEABLE DOPPLER FLOW PROBE
    Search all 12 clearances from Cook Vascular, Inc. →