21 CFR 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).

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

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.

  • 2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017
    1. 82 FR 12171 - Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective March 1, 2017.
      21 CFR Part 876
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