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510(k) Data Aggregation

    K Number
    K143481
    Device Name
    IntellaMap Orion High Resolution Mapping Catheter
    Manufacturer
    RHYTHMIA MEDICAL, INC
    Date Cleared
    2015-01-08

    (31 days)

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

    RHYTHMIA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
    Device Description
    The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.
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    K Number
    K130750
    Device Name
    RHYTHMIA MAPPING SYSTEM
    Manufacturer
    RHYTHMIA MEDICAL, INC
    Date Cleared
    2013-07-22

    (125 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    RHYTHMIA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythmia Mapping System and accessories are indicated for catheter based atrial and ventricular mapping. The mapping system allows real-time visualization of intra-cardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intra-cardiac electrograms, may also be recorded and displayed on the system's display screen.
    Device Description
    The Rhythmia Mapping System and accessories are designed for electroanatomical mapping and is able to simultaneously acquire data from multiple electrodes. The Rhythmia Mapping System tracks catheters inside the heart in order to visualize their location and construct geometric shells. The Rhythmia Mapping System is also capable of using intra-cardiac location and electrical information to display electroanatomical maps - electrical activity information on the constructed geometry. Such electrical information can be visualized in 3D in color. The Rhythmia Mapping System can display various types of electroanatomical maps including geometrical shell only, activation maps, voltage maps and fractionation maps.
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    K Number
    K122461
    Device Name
    RHYTHMIA MAPPING CATHETER
    Manufacturer
    RHYTHMIA MEDICAL, INC
    Date Cleared
    2013-04-18

    (248 days)

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

    RHYTHMIA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
    Device Description
    The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. The Rhythmia Catheter is an 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The Rhythmia Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment. The catheter can be connected to commercially available EP diagnostic systems such as recording systems or 3D mapping systems.
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