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510(k) Data Aggregation

    K Number
    K233900
    Device Name
    Nordica PV Cryo Mapping Catheter
    Manufacturer
    Synaptic Medical Corporation
    Date Cleared
    2024-09-06

    (270 days)

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

    Synaptic Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.
    Device Description
    The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.
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    K Number
    K240246
    Device Name
    Accusafe Transseptal Guidewire (GTR31180, GTR31230)
    Manufacturer
    Synaptic Medical Corporation
    Date Cleared
    2024-07-26

    (178 days)

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

    Synaptic Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K233708
    Device Name
    NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
    Manufacturer
    Synaptic Medical Corporation
    Date Cleared
    2024-02-16

    (88 days)

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

    Synaptic Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures. The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.
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    K Number
    K203793
    Device Name
    RithmID-SD Steerable Diagnostic Electrophysiology Catheter
    Manufacturer
    Synaptic Medical Corporation
    Date Cleared
    2022-02-14

    (413 days)

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

    Synaptic Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
    Device Description
    The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.
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