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 Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter With Lumen, Response Electrophysiology Catheter And Sjm Epicardial Catheter System, Supreme Elec.
| Device ID | K151622 |
| 510k Number | K151622 |
| Device Name: | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter With Lumen, Response Electrophysiology Catheter And SJM Epicardial Catheter System, Supreme Elec |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345 |
| Contact | Maria Obreztchikova |
| Correspondent | Maria Obreztchikova St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-16 |
| Decision Date | 2015-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734201490 | K151622 | 000 |
| 05414734201438 | K151622 | 000 |
| 05414734201155 | K151622 | 000 |
| 05414734201124 | K151622 | 000 |
| 05414734200493 | K151622 | 000 |