The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity System Referred To Ensite Velocity System With Positional Reference Tool (prt).
| Device ID | K101667 |
| 510k Number | K101667 |
| Device Name: | ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-14 |
| Decision Date | 2010-07-02 |
| Summary: | summary |