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510(k) Data Aggregation

    K Number
    K143463
    Device Name
    IS4/DF4 Port Plug
    Manufacturer
    Oscor Inc.
    Date Cleared
    2015-03-19

    (105 days)

    Product Code
    DTD
    Regulation Number
    870.3620
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle.
    Device Description
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    K Number
    K132008
    Device Name
    6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
    Manufacturer
    MEDTRONIC INC.
    Date Cleared
    2013-07-30

    (29 days)

    Product Code
    DTD
    Regulation Number
    870.3620
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard. The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard. The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard. The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard. The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings. The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
    Device Description
    The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard. The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard. The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard. The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard. The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings. The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
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    K Number
    K041574
    Device Name
    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
    Manufacturer
    GUIDANT CORPORATION
    Date Cleared
    2004-07-12

    (28 days)

    Product Code
    DTD
    Regulation Number
    870.3620
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals. 2) Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal. 3) Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.
    Device Description
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    K Number
    K031164
    Device Name
    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
    Manufacturer
    Oscor Inc.
    Date Cleared
    2003-06-19

    (66 days)

    Product Code
    DTD
    Regulation Number
    870.3620
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacing bipolar lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.
    Device Description
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    K Number
    K024156
    Device Name
    PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
    Manufacturer
    Oscor Inc.
    Date Cleared
    2003-01-14

    (28 days)

    Product Code
    DTD
    Regulation Number
    870.3620
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.
    Device Description
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