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510(k) Data Aggregation
K Number
K220032Device Name
iStent infinite Trabecular Micro-Bypass System, Model iS3
Manufacturer
Glaukos Corporation
Date Cleared
2022-08-02
(209 days)
Product Code
KYF
Regulation Number
886.3920Why did this record match?
Applicant Name (Manufacturer) :
Glaukos Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.
Device Description
The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The G2-W stents are manufactured from implant grade titanium (Ti6Al4V ELI per ASTM F136) and are coated with stearalkonium heparin. An area of reduced outside diameter, midway along the device, is designed to provide retention within the trabecular meshwork, while multiple outlet lateral lumens (4 outflow orifices) are designed to provide an exit route for aqueous from the anterior chamber. The stent has a single piece design, is 360 um in diameter, 360 um in height, and the central inlet and outlet lumen has a diameter of 80 um. The head of the stent has four side outlets that each have a diameter of 50 um.
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