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510(k) Data Aggregation

    K Number
    K090485
    Device Name
    COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
    Manufacturer
    PERCUTANEOUS SYSTEMS, INCORPORATED
    Date Cleared
    2009-07-22

    (147 days)

    Product Code
    LQR, FGE, GCA
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.
    Device Description
    The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.
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    K Number
    K061766
    Device Name
    EXPRESSWAY INTERMITTENT CATHETER
    Manufacturer
    PERCUTANEOUS SYSTEMS, INCORPORATED
    Date Cleared
    2007-03-09

    (260 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.
    Device Description
    The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.
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    K Number
    K052298
    Device Name
    CYSTOGLIDE INTRODUCER SHEATH
    Manufacturer
    PERCUTANEOUS SYSTEMS, INCORPORATED
    Date Cleared
    2006-12-12

    (476 days)

    Product Code
    KNY
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
    Device Description
    The CYSTOGLIDE INTRODUCER SHEATH consists of a film, a sheath, a stabilizing ring, and an obturator. The sheath is isolated from the skin microflora by the ViaShield film membrane.
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    K Number
    K052048
    Device Name
    ACCORDION
    Manufacturer
    PERCUTANEOUS SYSTEMS, INCORPORATED
    Date Cleared
    2005-09-13

    (46 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
    Device Description
    The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.
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    K Number
    K042531
    Device Name
    UPDATED SLIP UROLOGY INTRODUCER SHEATH
    Manufacturer
    PERCUTANEOUS SYSTEMS, INCORPORATED
    Date Cleared
    2005-02-01

    (137 days)

    Product Code
    KNY
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
    Device Description
    The UPDATED SLIP Urology Introducer Sheath consists of a membrane sheath, outer tube, stabilizing ring, and an obturator. The outer tube is pre-loaded with the membrane sheath.
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