21 CFR 876.5880 - Isolated kidney perfusion and transport system and accessories.

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§ 876.5880 Isolated kidney perfusion and transport system and accessories.

(a) Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

(b) Classification. Class II (performance standards).

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United States Code

Title 21 published on 2015-04-01

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

  • 2015-11-23; vol. 80 # 225 - Monday, November 23, 2015
    1. 80 FR 72899 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective November 23, 2015. The classification was applicable on April 27, 2012.
      21 CFR Part 876