(27 days)
The Lysus® 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 the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The documents are FDA letters regarding a 510(k) premarket notification for the Lysus Infusion System. They confirm substantial equivalence to a predicate device and provide administrative details, but do not outline performance acceptance criteria or study results.
§ 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).