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Code of Federal Regulations Title 21. Food and Drugs § 21.886.3920 Aqueous shunt

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.

(b) Classification. Class II. The special controls for this device are FDA's:

(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I:  Evaluation and Testing,’ ”

(2) “510(k) Sterility Review Guidance of 2/12/90 (K90–1),” and

(3) “Aqueous Shunts—510(k) Submissions.”

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.886.3920 Aqueous shunt - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-886-3920/

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