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510(k) Data Aggregation
K Number
K212593Device Name
ViaCath, AcQRate Dx Steerable Catheter
Manufacturer
Date Cleared
2021-10-15
(60 days)
Product Code
Regulation Number
870.1220Why 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.
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