The following data is part of a premarket notification filed by Irras Usa with the FDA for Irraflow Active Fluid Exchange System (afes).
| Device ID | K222471 |
| 510k Number | K222471 |
| Device Name: | IRRAflow Active Fluid Exchange System (AFES) |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | IRRAS USA 11975 El Camino Real, Suite 304 San Diego, CA 92130 |
| Contact | Jeanne S Warner |
| Correspondent | Jeanne S Warner IRRAS USA 11975 El Camino Real, Suite 304 San Diego, CA 92130 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-16 |
| Decision Date | 2022-12-08 |