The following data is part of a premarket notification filed by St. Jude Medical with the FDA for St. Jude Medical Mediguide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter.
| Device ID | K150631 |
| 510k Number | K150631 |
| Device Name: | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | St. Jude Medical 14901 De Veau Place Minnetonka, MN 55345 -2126 |
| Contact | Harlan Jones |
| Correspondent | Harlan Jones St. Jude Medical 14901 De Veau Place Minnetonka, MN 55345 -2126 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-04-01 |
| Summary: | summary |