21 CFR 876.5830 - Hemodialyzer with disposable insert (Kiil type).

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§ 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 2015-12-03

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

  • 2016-07-13; vol. 81 # 134 - Wednesday, July 13, 2016
    1. 81 FR 45229 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 13, 2016. The classification was applicable on June 3, 2016.
      21 CFR Part 876
The section you are viewing is cited by the following CFR sections.

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-07-13; vol. 81 # 134 - Wednesday, July 13, 2016
    1. 81 FR 45229 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 13, 2016. The classification was applicable on June 3, 2016.
      21 CFR Part 876