CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 876—GASTROENTEROLOGY-UROLOGY DEVICES > SUBPART F—Therapeutic Devices (§876.5010 to §876.5990) > 876.5830—Hemodialyzer with disposable insert (Kiil type).

876.5830—Hemodialyzer with disposable insert (Kiil type).

(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).

Code of Federal Regulations

[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]