The following data is part of a premarket notification filed by Irras Inc. with the FDA for Irraflow Cns System.
| Device ID | K171880 |
| 510k Number | K171880 |
| Device Name: | IRRAflow CNS System |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | IRRAS Inc. 7452 Herschel Avenue La Jolla, CA 92037 |
| Contact | Dessi Lyakov |
| Correspondent | Dessi Lyakov IRRAS Inc. 7452 Herschel Avenue La Jolla, CA 92037 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-23 |
| Decision Date | 2018-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868643000432 | K171880 | 000 |
| 00868643000425 | K171880 | 000 |
| 00868643000418 | K171880 | 000 |
| 10868643000408 | K171880 | 000 |
| 10868643000477 | K171880 | 000 |