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510(k) Data Aggregation

    K Number
    K210313
    Device Name
    EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
    Manufacturer
    Shanghai MicroPort EP MedTech Co., Ltd.
    Date Cleared
    2022-12-30

    (695 days)

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

    Shanghai MicroPort EP MedTech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
    Device Description
    The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves. The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.
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    K Number
    K212625
    Device Name
    PathBuilder Transseptal Needle
    Manufacturer
    Shanghai MicroPort EP MedTech Co., Ltd.
    Date Cleared
    2022-03-23

    (217 days)

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

    Shanghai MicroPort EP MedTech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
    Device Description
    PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.
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    K Number
    K212626
    Device Name
    PathBuilder Transseptal Guiding Introducer
    Manufacturer
    Shanghai MicroPort EP MedTech Co., Ltd.
    Date Cleared
    2022-03-23

    (217 days)

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

    Shanghai MicroPort EP MedTech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PathBuilder™ Transseptal Guiding Introducer is introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
    Device Description
    PathBuilder™ Transseptal Guiding Introducer is comprised of a sheath, a dilator and a guidewire. At the distal end of the sheath, a marker band is embedded to mark the position of the sheath during the procedure. Near the marker band, there are three vent holes to reduce cavitation during aspiration and device withdrawal. At the proximal end of the sheath, a sideport with three-way stopcock is located for aspiration, fluid infusion, blood sampling and pressure monitoring. Sheath is fitted with a valve to provide hemostasis during catheter introduction and/or exchange over a guidewire. The dilator, which is mainly used to expand the opening during the inter-atrial septal puncture, is a straight tube with a specially curved portion. The distal end of the dilator is designed to a tip and there is a hub at the proximal end where the needle goes through. The internal lumen of dilator is tapered at the distal tip to fix the location of the needle. Both the sheath and dilator are with a specially curved portion to accommodate positioning against the atrial septum. When the dilator is inserted into the sheath, the sheath tip fit that of dilator well, which help the set to enter the sheath. Guidewire is a thin wire leading the introducer set to the desired position.
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    K Number
    K211530
    Device Name
    PathBuilder Steerable Introducer
    Manufacturer
    Shanghai MicroPort EP MedTech Co., Ltd.
    Date Cleared
    2022-02-08

    (267 days)

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

    Shanghai MicroPort EP MedTech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PathBuilder™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart. The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of dilator has a fixed curve to adapt to the heart structure. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
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