21 CFR 876.5830

§ 876.5830 Hemodialyzer with disposable insert (Kiil type).

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 876.5830, § 876.5830 Hemodialyzer with disposable insert (Kiil type), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90355
Permanent ID: ys:prov:90355@1
SHA-256: 9b2a5232dd852e5991f5e47023d8a1025c20e4725cc0e4e6aa4cd2d6f9f6ad07

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Full text

(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.