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510(k) Data Aggregation

    K Number
    K133853
    Device Name
    VIEWFLEX XTRA ICE CATHETER
    Manufacturer
    IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY
    Date Cleared
    2014-05-19

    (151 days)

    Product Code
    OBJ
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE BIOMEDICAL, INC. A ST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
    Device Description
    The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.
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    K Number
    K082061
    Device Name
    INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    2008-08-19

    (29 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV catheters are to be used to map the atrial regions of the heart.
    Device Description
    The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop which is parallel to catheter body. The loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
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    K Number
    K060757
    Device Name
    INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    2006-04-19

    (29 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the atrial regions of the heart.
    Device Description
    The Inquiry Optima PLUS Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop and on the shaft of the catheter also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
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    K Number
    K053582
    Device Name
    INQUIRY AFOCUS II DIAGNOSTIC CATHETER
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    2006-03-21

    (88 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions of the heart.
    Device Description
    The Inquiry AFocusII™ Bi-Directional Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop are steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
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    K Number
    K042775
    Device Name
    INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    2004-11-04

    (29 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steerable Electrophysiology Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheter is indicated for mapping the atrial regions of the heart.
    Device Description
    The Inquiry™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loon in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
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    K Number
    K010471
    Device Name
    AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    2001-06-06

    (106 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991878
    Device Name
    LUMA-CATH STEERABLE EP CATHETERS
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    1999-12-10

    (191 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBI Luma-Cath™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the His bundle.
    Device Description
    The Irvine Biomedical, Inc. Luma-Cath™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 6 and 8 French. The diameter of the electrodes is between 6 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch.
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    K Number
    K991025
    Device Name
    LUMA-CATH FIXED CURVE EP CATHETERS
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    1999-10-15

    (200 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.
    Device Description
    The Irvine Biomedical, Inc. Luma-Cath™ Fixed Curve Electriophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the electrodes is between 5 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch for insertion of a guidewire.
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    K Number
    K990958
    Device Name
    ORTHOGONAL EP CATHETERS
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    1999-06-03

    (73 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTHOGONAL TM Electrophysiology Catheters are used forelectrogram recording and cardiac stimulation during diagnosticelectrophysiologic studies. The electrophysiology catheters arecommonly placed at the high right atrium, right ventricular apex,and His bundle.
    Device Description
    The Irvine Biomedical, Inc. ORTHOGONAL™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
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    K Number
    K982232
    Device Name
    MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Date Cleared
    1998-07-25

    (30 days)

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

    IRVINE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
    Device Description
    The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
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