The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Inivox Electrode/catheter Sys.
| Device ID | K832916 |
| 510k Number | K832916 |
| Device Name: | INIVOX ELECTRODE/CATHETER SYS |
| Classification | Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LLE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-29 |
| Decision Date | 1983-11-14 |