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

§ 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).

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 19-May-2018 03:57

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

  • 2017-11-14; vol. 82 # 218 - Tuesday, November 14, 2017
    1. 82 FR 52649 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective November 14, 2017. The classification was applicable on June 21, 2017.
      21 CFR Part 876