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

    IPI LOW PROFILE IMPORT

    K Number: K934796 · Decision Jul 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    40
    Review Days
    281

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    Basic Information

    Device Name
    IPI LOW PROFILE IMPORT
    K Number
    K934796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pudenz-Schulte Medical Research Corp.
    Date Received
    October 6, 1993
    Decision Date
    July 14, 1994
    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

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    Other Clearances by Pudenz-Schulte Medical Research Corp.

    K Number Device Name
    K960055 MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
    K954409 PS MEDICAL IPI VASCULAR ACCESS CATHETER
    K951258 PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
    K934167 IPI DUAL LUMEN PORT
    K940096 PS MEDICAL CATHETER PLACEMENT KIT
    K934545 PS MEDICAL DELTA BURR HOLE VALVE
    K930206 PS MEDICAL IPI ACCESS KIT
    K930606 PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
    K913412 PS MEDICAL CSF-ACCESS DEVICE
    K922419 IPI IMPORT
    Search all 40 clearances from Pudenz-Schulte Medical Research Corp. →