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510(k) Data Aggregation
K Number
K222023Device Name
RayFlow
Manufacturer
Date Cleared
2023-04-06
(269 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Hexacath
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. The RayFlow is not intended to be used in the neurovasculature.
Device Description
The RAYFLOW infusion catheter is a rapid exchange (RX) double lumen catheter with a series of holes and a radiopaque marker on its distal part. The outer lumen along the entire length of the catheter is used to inject fluids (saline, medication or contrast media) through the holes. The inner RX lumen is dedicated to the passage of a 0.014" quidewire facilitating the progression of the RAYFLOW catheter through the arteries. Four holes are located between the outer lumen and the surface of the catheter, allowing infusion of fluids into the blood resulting in a homogeneous mixing. Two holes located between the outer and inner lumen of the RAYFLOW catheter allow the measurement of the injected solution temperature by a specific pressure/temperature guidewire (Abbott PressureWire™ X Guidewire) at the moment the solution enters the artery. The hub is standard sized and compatible with any automated pump injector used for the continuous infusion of saline/liquid at room temperature. The RAYFLOW is provided sterilized with ethylene oxide. This device is for a single use only and packed in individual unit. A mandrel is inserted into the inner lumen to protect the integrity of the device.
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