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510(k) Data Aggregation

    K Number
    K020379
    Device Name
    PPD BALLOON DILATATION CATHETER
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    2002-05-06

    (90 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dillatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.
    Device Description
    The PPD Balloon Dilatation Catheter consists of a polymer balloon mounted on a plastic shaft. The balloon can be inflated to different diameters depending on the inflation pressure; each balloon is capable of inflation to three or four distinct and progressively larger sized diameters at the recommended pressures. Proximal luer connectors are provided for balloon inflation and quidewire passage.
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    K Number
    K013737
    Device Name
    MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    2002-03-01

    (108 days)

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

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleMed Systems 3-Lumen Occlusion Balloon Catheter is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.
    Device Description
    The 3-Lumen Occlusion Balloon consists of a compliant polymer balloon mounted on a plastic shaft. The shaft has 3 internal lumens, each of which terminates in a proximal connector and connection tube. The lumens are used for balloon inflation, guidewire passage and distal fluid injection.
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    K Number
    K010412
    Device Name
    FLEXIBLE ENDOSCOPIC SCISSORS
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    2001-04-02

    (49 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use for cutting of tissue when used through the working channel of a flexible or rigid endoscope.
    Device Description
    The TeleMed Systems Flexible Endoscopic Scissors are reusable, metallic surgical scissors that may be passed through a gastrointestinal endoscope and used to incise tissue.
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    K Number
    K992390
    Device Name
    HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    1999-12-22

    (156 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract.
    Device Description
    Not Found
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    K Number
    K992402
    Device Name
    5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    1999-12-22

    (156 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.
    Device Description
    Three Lumen Papillotome/Sphincterotome
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    K Number
    K974312
    Device Name
    REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    1998-01-21

    (65 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs
    Device Description
    Reusable Biopsy Forceps
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    K Number
    K974300
    Device Name
    TELEMED SYSTEMS RETRIEVAL BASKET
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    1997-12-19

    (32 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEMED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tele Med Systems, INC. Retrieval Basket is for use with The Endoscopic Gate I track.
    Device Description
    Retrieval Basket
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