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

    GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION

    K Number: K905463 · Decision Jan 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    14
    Review Days
    48

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    Basic Information

    Device Name
    GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION
    K Number
    K905463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Angiosystems, Inc.
    Date Received
    December 5, 1990
    Decision Date
    January 22, 1991
    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 Angiosystems, Inc.

    K Number Device Name
    K905464 MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
    K905459 SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM
    K905461 PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
    K905466 STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE
    K905465 STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE
    K905460 STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY
    K905462 PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES
    K864688 ARNOLD-KING PRESSURE DRESSING
    K843258 ANGIO SYS BRACHIAL ANGIO DRAPE
    K843259 ANGIO SYS FLUOROSCOPE DRAPE
    Search all 14 clearances from Angiosystems, Inc. →