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K Number
K243928Device Name
ViaOne Epicardial Access System
Manufacturer
CardioVia Ltd.
Date Cleared
2025-03-20
(90 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
CardioVia Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ViaOne Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.
Device Description
ViaOne Epicardial Access System is a sterile, single-use access tool consisting of a concealed needle within a leading channel to facilitate guidewire access into the pericardium through a subxiphoid incision. The device consists of a radiopaque distal tip designed to retract a portion of the pericardial tissue into the device, and away from the heart muscle, where it is punctured by the concealed needle and a guidewire is introduced into the pericardial space.
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