21 CFR 886.3920 — Implant, Eye Valve
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3920
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.
Classification Rationale
Class II. The special controls for this device are FDA's:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KYF | Implant, Eye Valve | 2 | 25 | Implant |
Special Controls
KYF — Implant, Eye Valve
*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.”
eCFR
KYF — Implant, Eye Valve
(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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