BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER

    K Number: K930606 · Decision Sep 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    22
    Same Product Code
    12
    Applicant Total
    40
    Review Days
    217

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    Basic Information

    Device Name
    PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
    K Number
    K930606
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.4545
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pudenz-Schulte Medical Research Corp.
    Date Received
    February 5, 1993
    Decision Date
    September 10, 1993
    Product Code
    GYK
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GYK Instrument, Shunt System Implantation

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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
    K934796 IPI LOW PROFILE IMPORT
    K934167 IPI DUAL LUMEN PORT
    K940096 PS MEDICAL CATHETER PLACEMENT KIT
    K934545 PS MEDICAL DELTA BURR HOLE VALVE
    K930206 PS MEDICAL IPI ACCESS KIT
    K913412 PS MEDICAL CSF-ACCESS DEVICE
    K922419 IPI IMPORT
    Search all 40 clearances from Pudenz-Schulte Medical Research Corp. →