The following data is part of a premarket notification filed by Vygon Neuro with the FDA for Neurocath Ag.
| Device ID | K081942 |
| 510k Number | K081942 |
| Device Name: | NEUROCATH AG |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | VYGON NEURO 2495 GENERAL ARMISTEAD AVE. Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON NEURO 2495 GENERAL ARMISTEAD AVE. Norristown, PA 19403 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-08 |
| Decision Date | 2008-08-12 |
| Summary: | summary |