FDA.reportPublic FDA data

iStent Infinite

Primary DI
00853704002449
Brand
iStent Infinite
Company
GLAUKOS CORPORATION
Model
iS3
Catalog number
iS3-US
Device description
Trabecular Micro-Bypass System
Published
2022-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYFImplant, Eye Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYFImplant, Eye ValveOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220032000iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation2022-08-02KYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853704002449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853704002449008537040024498537040024490853704002449

GMDN Terms#

Term, Definition table
TermDefinition
Glaucoma micro-stentA non-bioabsorbable device designed to be implanted in Schlemm’s canal (within the eye) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. It is a metallic device which may be intended to dilate, support, and/or create a channel into Schlemm’s canal; disposable devices associated with implantation (e.g., delivery system) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-367-9600Quality@glaukos.com

Regulatory Flags#

DUNS number
012835406
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853704002456iPRIMEVCP100VCP1002022-05-13
00853704002487iStent inject W Trabecular Micro-Bypass System with Infinite Injector TechnologyiS2iS22025-04-30
00853704002470iStent infiniteiS3iS32022-10-05
00853704002319iStent inject WG2-WG2-W2020-08-11
00853704002005iStentGTS100RGTS100R2015-09-21
00853704002012iStentGTS100LGTS100L2015-09-21
00853704002029iStentGTS100iGTS100i2015-09-21
00853704002203iStent injectG2-M-ISG2-M-IS2018-07-25
00853704002463iAccessAX1AX12022-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380650500045EX-PRESSAlcon Laboratories, Inc.KYF2025-09-23
00892064002089Ahmed ClearPath STNEW WORLD MEDICAL, INCORPORATEDKYF2024-12-18
00892064002096Ahmed ClearPath STNEW WORLD MEDICAL, INCORPORATEDKYF2024-12-18
00853704002470iStent infiniteGLAUKOS CORPORATIONKYF2022-10-05
00892064002188Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2020-08-12
00892064002348Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATEDKYF2019-01-23
00892064002355Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATEDKYF2019-01-23
10888628032439XEN Glaucoma Treatment SystemAllergan, Inc.KYF2018-01-30
00892064002126Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2017-09-08
00892064002119Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2016-11-16
09419196000014MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000021MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000038MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000052MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000069MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000076MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000083MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000090Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000106Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000212Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000229Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
00380650704931EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
00380650704948EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
05050474512993BAERVELDT GLAUCOMA IMPLANT (350)JOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
05050474513006BAERVELDT PARS PLANA GLAUCOMA IMPLANTJOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
05050474513013BAERVELDT GLAUCOMA IMPLANT (250)JOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
00892064002140Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24
00892064002270Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24
00892064002133Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24