21 C.F.R. § 876.5830 Hemodialyzer with disposable insert (Kiil type).
Title 21 - Food and Drugs
(a) Identification. A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers of semipermeable membranes which are sandwiched between support plates. The device is used with the extracorporeal blood system and the dialysate delivery system of the hemodialysis system and accessories (§876.5820). (b) Classification. Class II (performance standards). [48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices
§ 876.5830 Hemodialyzer with disposable insert (Kiil type).
