The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Polaris Pressure Adjustable Valve System/polaris Adjustable Valve With Siphonx.
| Device ID | K141227 |
| 510k Number | K141227 |
| Device Name: | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | SOPHYSA SA 25108 MARGUERITE PARKWAY, SUITE A-354 Mission Viejo, CA 92692 |
| Contact | Gustavo Kobrin |
| Correspondent | Gustavo Kobrin SOPHYSA SA 25108 MARGUERITE PARKWAY, SUITE A-354 Mission Viejo, CA 92692 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-12 |
| Decision Date | 2015-04-02 |