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510(k) Data Aggregation

    K Number
    K160223
    Device Name
    VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2016-04-08

    (70 days)

    Product Code
    NHC
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    NHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
    Device Description
    The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation consists of a VentriClear® Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closed-end configuration with 16 standard and 16 small sideports. The VentriClear® Ventricular Drainage Catheter has markings at 1 cm increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin. The VentriClear® II Ventricular Drainage Catheter consists of a VentriClear® II Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® II Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closedend configuration with 16 sideports. The VentriClear® II Ventricular Drainage Catheter has markings at 1 cm increments, starting at the 3 cm mark and extending to 33 cm, to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® II Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.
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    K Number
    K071640
    Device Name
    VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
    Manufacturer
    COOK, INC.
    Date Cleared
    2007-07-12

    (27 days)

    Product Code
    NHC
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    NHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
    Device Description
    Spectrum® VentriClear™ II Ventricular Drainage Catheter Set includes a silicone 2.8 mm (9 Fr.) ventricular catheter available in a 33 cm length with numbered markings and 16 sideports. VentriClear™ II is impregnated with minocycline and rifampin. This device is supplied sterile and is intended for one-time use.
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    K Number
    K011812
    Device Name
    SPECTRUM VENTRICULAR CATHETER
    Manufacturer
    COOK, INC.
    Date Cleared
    2001-11-08

    (150 days)

    Product Code
    NHC
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    NHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPECTRUM® Ventricular Catheter is intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume. The device will be supplied sterile and is intended for one-time use.
    Device Description
    The SPECTRUM® Ventricular Catheter is a 9 Fr catheter nominally 33 cm in length. The catheter has a closed-end configuration with nominally 16 sideports, and has markings at 1 cm increments to aid in determining depth of placement. The SPECTRUM® Ventricular Catheter is impregnated with an antimicrobial combination of minocycline and rifampin which may reduce the risk of catheter related infection during use. Based on HPCC analysis, the average amount of minocycline on the catheter is approximately 5 mg (159 Φg/cm), and the average amount of rifampin on the catheter is approximately 4 mg (116 @g/cm). Components supplied with the SPECTRUM® Ventricular Catheter include a pre-loaded stainless steel stylet, a stainless steel tunneling trocar, and proximal fittings, which are included to facilitate placement and use of the Ventricular Catheter.
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