Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212593
    Device Name
    ViaCath, AcQRate Dx Steerable Catheter
    Manufacturer
    Date Cleared
    2021-10-15

    (60 days)

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

    Biotronick, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The catheter is intended for use in diagnostic electrophysiologic procedures in adult patients. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
    Device Description
    The ViaCath* and the AcQRate Dx Steerable Catheters are temporary, steerable, multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device. The main components of the ViaCath catheter are the distal catheter tip with electrodes, catheter shaft, handle, and connecting cable with pluq, which is a Redel connector. The ViaCath product family includes the ViaCath and the ViaCath NG models. Multiple electrode configurations are available with various numbers of electrodes, electrode shapes and electrode spacing. * Unless otherwise noted, the term "ViaCath" is used throuqhout to represent either ViaCath or AcQRate Dx Steerable Catheter.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1