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

    IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM

    K Number: K881342 · Decision Aug 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    9
    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
    IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM
    K Number
    K881342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Burron Medical, Inc.
    Date Received
    March 30, 1988
    Decision Date
    August 9, 1988
    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 Burron Medical, Inc.

    K Number Device Name
    K902401 CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
    K896422 BURRON AMBULATORY DRUG DELIVERY SYSTEM
    K884235 COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
    K895191 ANTI-THROMBOGENIC COATING FOR CATHETERS
    K895192 SPINOCAN(R) CONTINUOUS SPINAL TRAY
    K884183 BURRON TEFLON-COATED GUIDEWIRE
    K882106 PERFUSOR M SYRINGE PUMP
    K882107 PERFUSOR SECURA SYRINGE PUMP