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510(k) Data Aggregation

    K Number
    K012520
    Device Name
    GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
    Date Cleared
    2002-03-27

    (233 days)

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

    CARDIAC ASSIST DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.
    Device Description
    The Gyro-Tip Lariat Deflectable Loop Mapping Catheter of Cardiac Assist Devices, Inc. has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures. The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices. The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures. The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety.
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    K Number
    K960849
    Device Name
    MAGNO ALARM
    Date Cleared
    1997-03-26

    (400 days)

    Product Code
    Regulation Number
    870.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIAC ASSIST DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.
    Device Description
    a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.
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    K Number
    K955847
    Device Name
    GYRO TIP EP CATHETER
    Date Cleared
    1997-01-29

    (400 days)

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

    CARDIAC ASSIST DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Monitor and record intra-cardiac electrical activities
    Device Description
    Not Found
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