The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity System.
| Device ID | K130594 |
| 510k Number | K130594 |
| Device Name: | ENSITE VELOCITY SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Donna R Lunak |
| Correspondent | Donna R Lunak 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 | 2013-03-07 |
| Decision Date | 2013-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067003867 | K130594 | 000 |
| 05414734211239 | K130594 | 000 |
| 05414734210188 | K130594 | 000 |
| 05415067000026 | K130594 | 000 |
| 05414734210218 | K130594 | 000 |
| 05414734210195 | K130594 | 000 |
| 05414734210706 | K130594 | 000 |