(28 days)
The EndoWave® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily a notification from the FDA regarding an administrative change to a previously issued substantial equivalence letter for the EndoWave Infusion System. It mentions the device's intended use and briefly describes its components, but it does not detail any performance metrics, studies, or results that would correspond to the questions asked.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).