(70 days)
The Allient Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
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This document is a 510(k) clearance letter for the Allient Sorbent Hemodialysis System. It does not contain information on the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance data that led to this determination.
Therefore, I cannot provide the requested table or information based on the content of this document.
§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a)
Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.(b)
Classification. Class II (performance standards).