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510(k) Data Aggregation
K Number
K241851Device Name
Versus Catheter (VS110-8B)
Manufacturer
Liquet Medical Inc.
Date Cleared
2024-11-25
(151 days)
Product Code
QEY, DQO, DYG, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Liquet Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Versus™ Catheter is indicated for:
The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.
The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.
Device Description
The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.
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