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

    PBC SCALP VEIN SET

    K Number: K834255 · Decision Mar 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    11
    Review Days
    96

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    Basic Information

    Device Name
    PBC SCALP VEIN SET
    K Number
    K834255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Philadelphia Biologics Center
    Date Received
    December 7, 1983
    Decision Date
    March 12, 1984
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Philadelphia Biologics Center

    K Number Device Name
    K841717 INTRAVENOUS INJECTION SET
    K834256 PBC SYRINGE IRRIGATING
    K834254 PBC IV SET VENTED
    K834252 PBC EXTENSION SET
    K834253 PBC IV SET NON-VENTED
    K820911 PBC NEEDLE BY NIPRO MED. INDUSTRIES
    K813649 PBC NEEDLE
    K813646 JMS DISPOSABLE SYRINGE
    K813648 JMS NEEDLE & MAC JECT
    K813647 PBC SYRINGE
    Search all 11 clearances from Philadelphia Biologics Center →