The following data is part of a premarket notification filed by Irras Usa, Ltd. with the FDA for Irraflow Catheter, Irraflow Tube Set, Irraflow Control Unit.
| Device ID | K192289 |
| 510k Number | K192289 |
| Device Name: | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | IRRAS USA, Ltd. 11975 El Camino Real, Suite 304 San Diego, CA 92130 |
| Contact | Vinny Podichetty |
| Correspondent | Niloufa Insanally IRRAS USA, Ltd. 11975 El Camino Real, 3rd Floor San Diego, CA 92130 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2019-11-15 |