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510(k) Data Aggregation

    K Number
    K171583
    Device Name
    RhythmView Workstation
    Manufacturer
    Abbott Electrophysiology
    Date Cleared
    2017-09-01

    (93 days)

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

    Abbott Electrophysiology

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    RhythmView uses electrical signals collected from the electrodes of one or more multi-polar electrophysiology (EP) catheters. It provides a dynamic, simplified representation of wave propagation. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K163709
    Device Name
    FIRMap Catheter
    Manufacturer
    ABBOTT ELECTROPHYSIOLOGY
    Date Cleared
    2017-02-28

    (60 days)

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

    ABBOTT ELECTROPHYSIOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.
    Device Description
    The FIRMap Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.
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    K Number
    K161240
    Device Name
    Rhythm View Workstation (non-streaming)
    Manufacturer
    Abbott Electrophysiology
    Date Cleared
    2016-08-10

    (100 days)

    Product Code
    DQK, 870
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Electrophysiology

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Software, Keyboard, Mouse, Two Port USB Switch, Solid State Hard Drive (optional component). RhythmView takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K153093
    Device Name
    FIRMap Catheter
    Manufacturer
    ABBOTT ELECTROPHYSIOLOGY
    Date Cleared
    2016-04-07

    (164 days)

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

    ABBOTT ELECTROPHYSIOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.
    Device Description
    The catheter is used in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.
    Ask a Question

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