21 C.F.R. § 886.3920 Aqueous shunt.
Title 21 - Food and Drugs
(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.” [65 FR 17147, Mar. 31, 2000, as amended at 66 FR 18542, Apr. 10, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices
§ 886.3920 Aqueous shunt.
