The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity Surface Electrode Kit.
| Device ID | K160186 |
| 510k Number | K160186 |
| Device Name: | EnSite Velocity Surface Electrode Kit |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL ONE ST. JUDE MEDICAL DRIVE St.paul, MN 55117 |
| Contact | Yumi Wackerfuss |
| Correspondent | Yumi Wackerfuss ST. JUDE MEDICAL ONE ST. JUDE MEDICAL DRIVE St.paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-10-07 |
| Summary: | summary |