The following data is part of a premarket notification filed by Glaukos Corporation with the FDA for Istent Infinite Trabecular Micro-bypass System, Model Is3.
| Device ID | K220032 |
| 510k Number | K220032 |
| Device Name: | IStent Infinite Trabecular Micro-Bypass System, Model IS3 |
| Classification | Implant, Eye Valve |
| Applicant | Glaukos Corporation 229 Avenida Fabricante San Clemente, CA 92672 |
| Contact | David S. Fernquist |
| Correspondent | David S. Fernquist Glaukos Corporation 229 Avenida Fabricante San Clemente, CA 92672 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853704002470 | K220032 | 000 |
| 00853704002449 | K220032 | 000 |