The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity System.
| Device ID | K141050 |
| 510k Number | K141050 |
| 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 | 2014-04-23 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067024909 | K141050 | 000 |
| 05414734213684 | K141050 | 000 |
| 05414734213660 | K141050 | 000 |
| 05414734210942 | K141050 | 000 |
| 05414734210713 | K141050 | 000 |
| 05414734210614 | K141050 | 000 |
| 05414734210522 | K141050 | 000 |
| 05414734210492 | K141050 | 000 |
| 05415067001061 | K141050 | 000 |
| 05415067014573 | K141050 | 000 |
| 05414734209953 | K141050 | 000 |
| 05414734213738 | K141050 | 000 |
| 05414734214636 | K141050 | 000 |
| 05415067024848 | K141050 | 000 |
| 05415067024831 | K141050 | 000 |
| 05415067014856 | K141050 | 000 |
| 05415067012173 | K141050 | 000 |
| 05415067005861 | K141050 | 000 |
| 05415067002952 | K141050 | 000 |
| 05415067002938 | K141050 | 000 |
| 05415067002921 | K141050 | 000 |
| 05415067001054 | K141050 | 000 |
| 05414734214841 | K141050 | 000 |
| 05415067003027 | K141050 | 000 |