The following data is part of a premarket notification filed by Covidien Llc with the FDA for Superdimension Navigation System.
| Device ID | K151376 |
| 510k Number | K151376 |
| Device Name: | SuperDimension Navigation System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Covidien LLC 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Contact | Jenny Jiang |
| Correspondent | Jenny Jiang Covidien LLC 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-22 |
| Decision Date | 2015-11-05 |
| Summary: | summary |