The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Precision Cardiac Mapping System V2.0.
| Device ID | K160210 |
| 510k Number | K160210 |
| Device Name: | EnSite Precision Cardiac Mapping System V2.0 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL One St. Jude Medical Dr St. Paul, MN 55117 |
| Contact | Marlene Peterson |
| Correspondent | Marlene Peterson ST. JUDE MEDICAL One St. Jude Medical Dr 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 | 2016-01-28 |
| Decision Date | 2016-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067024701 | K160210 | 000 |
| 05415067024725 | K160210 | 000 |
| 05415067026118 | K160210 | 000 |
| 05415067026163 | K160210 | 000 |
| 05415067026231 | K160210 | 000 |
| 05415067026248 | K160210 | 000 |
| 05415067026279 | K160210 | 000 |
| 15415067025934 | K160210 | 000 |
| 05415067024718 | K160210 | 000 |
| 05415067024756 | K160210 | 000 |
| 05415067025265 | K160210 | 000 |
| 05415067026125 | K160210 | 000 |
| 05415067026309 | K160210 | 000 |
| 05415067026316 | K160210 | 000 |
| 05415067027580 | K160210 | 000 |
| 05415067024695 | K160210 | 000 |
| 05415067025937 | K160210 | 000 |