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510(k) Data Aggregation
K Number
K142598Device Name
Opto Wire and OptoMonitor System
Manufacturer
Opsens, Inc.
Date Cleared
2015-06-12
(270 days)
Product Code
DQX, DXO
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Opsens, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
Device Description
The OptoWire and OptoMonitor System includes a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. The OptoWire and OptoWire cable are sterile, single-use devices; the remaining system components are reusable.
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