The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity Cardiac Mapping System V5.2.
| Device ID | K172396 |
| 510k Number | K172396 |
| Device Name: | EnSite Velocity Cardiac Mapping System V5.2 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Melissa Frank |
| Correspondent | Jack Kromenhoek 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 | 2017-08-08 |
| Decision Date | 2018-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067029256 | K172396 | 000 |
| 05415067027528 | K172396 | 000 |