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510(k) Data Aggregation

    K Number
    K971504
    Device Name
    HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
    Manufacturer
    J-LLOYD MEDICAL, INC.
    Date Cleared
    1998-04-20

    (360 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    J-LLOYD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hexapolar Electrode Balloon Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following: 1. Temporary use in electrophysiology studies; 2. Intra-cardiac ECG; and 3. Electrical stimulation.
    Device Description
    The Hexapolar Electrode Balloon Flotation Catheter (HEBFC) is furnished in both five and seven French sizes. The device has an electrode mounted at the distal tip with a latex balloon proximal to the tip electrode. There are five electrodes mounted on the shaft proximal to the balloon. The shaft has bands every ten centimeters. At the manifold, the extension with a Stopcock is connected to the Air Lumen. The electrode wire are connected to wire extensions with pin connectors. These are coded with numbers for identification.
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    K Number
    K973639
    Device Name
    ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
    Manufacturer
    J-LLOYD MEDICAL, INC.
    Date Cleared
    1998-04-20

    (208 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    J-LLOYD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrode Semi-Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following: 1. Temporary use in electrophysiology studies; 2. Intra-cardiac ECG; and 3. Electrical stimulation.
    Device Description
    The Electrode Semi-Flotation Catheter is furnished in five, six and seven French sizes. The device has an electrode mounted at the distal tip. There are one to five electrodes mounted on the shaft proximal to the tip. The shaft has bands every ten centimeters. The electrode wires are connected to wire extensions with pin connectors. These are coded with numbers for identification.
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    K Number
    K974335
    Device Name
    EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
    Manufacturer
    J-LLOYD MEDICAL, INC.
    Date Cleared
    1998-02-13

    (87 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    J-LLOYD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This catherer is intended for: - Temporarily occlude blood vessel. - Irrigating facility for heparin or contrast media. - USed for the non-surgical removal of emboli and thrombi,
    Device Description
    This balloon catheter is furnished in three, four, five, six, seven, eight and nine French sizes. The device has an balloon mounted at the distal tip. The shaft has bands every ten centimeters. The proximal end has a manifold and one extension with a hub and a second extension with a stopcock.
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    K Number
    K974336
    Device Name
    CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
    Manufacturer
    J-LLOYD MEDICAL, INC.
    Date Cleared
    1998-02-13

    (87 days)

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

    J-LLOYD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The catherer is designed to provide vital diagnostic information. It is indicated for: Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures.
    Device Description
    This Cholangiographic Balloon Catheter is furnished in four French two lumen size, with a radiopaque band proximal to the balloon
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    K Number
    K963248
    Device Name
    FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
    Manufacturer
    J-LLOYD MEDICAL, INC.
    Date Cleared
    1997-02-03

    (168 days)

    Product Code
    DYG
    Regulation Number
    870.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    J-LLOYD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output.
    Device Description
    Flow Directed Thermodilution / Infusion Balloon Catheter
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