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510(k) Data Aggregation

    K Number
    K151936
    Device Name
    Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
    Manufacturer
    SYNAPTIC MEDICAL LIMITED
    Date Cleared
    2015-12-04

    (143 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNAPTIC MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steerable Intracardiac Catheter Introducer Kit is intended to introduce various catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The proposed device includes Steerable Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. The Steerable Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right and left side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure. The Steerable Intracardiac Catheter Introducer Kit includes three components, which are (1) steerable sheath introducer, (2) dilator and (3) guidewire. The steerable sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration: Dilator is assembled with the sheath introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart. The handle of Steerable Intracardiac Catheter Introducer is equipped with the rotation collar, turn the collar in clockwise, the tip can be stered from 0 to 180 degree(s), while turn the collar in counterclockwise, the tip can be steered from 0 to 90 degree(s) on the other side. The transseptal needle includes two components, which are (1) stylet. The needle is used to puncture the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle lumen intact during handling and facilitate the needle advancement within the dilator. The kit and the transseptal needle are provided sterilized. They are subject to Ethylene Oxide sterilization prior to release. The Sterility Assurance Level (SAL) is 10-6. The shelf life of the proposed device is three (3) years.
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    K Number
    K132943
    Device Name
    INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
    Manufacturer
    SYNAPTIC MEDICAL LIMITED
    Date Cleared
    2014-08-29

    (344 days)

    Product Code
    DRC, DYB, NKQ
    Regulation Number
    870.1390
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNAPTIC MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
    Device Description
    The proposed device includes Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure. The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration; Dilator is assembled with the sheath introducer and introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart. The transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.
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    K Number
    K133028
    Device Name
    RITHM ID ELECTROPHYSIOLOGY CATHETER
    Manufacturer
    SYNAPTIC MEDICAL LIMITED
    Date Cleared
    2014-03-04

    (159 days)

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

    SYNAPTIC MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rithm ID™ Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
    Device Description
    The Rithm ID™ Electrophysiology Catheters have been designed to facilitate electrophysiological mapping of cardiac structures in 115 models and 17 kind of curves. The catheter has a high-torque shaft with an array of platinum electrodes at the distal tip that can be used for recording. The high-torque shaft allows the plane of the distal curve to be manually rotated to assist in positioning the catheter tip at the desired site. The Rithm IDM Electrophysiology Catheters have to connect with the EP by interface cables, model CI8RS04S, C25S04S, C18RS10S and C25RS10S with different trunk length, leadwire and equipment connector for the different Electrophysiology Catheters.
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