The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Advisor Fl 15mm 12 Pole 333 Uni D, Advisor Fl 20mm 12 Pole 555 Uni D, Advisor Fl 15mm 12 Pole 333 Bi D, Advisor Fl 20mm 12 Pole 555 Bi D.
| Device ID | K160335 |
| 510k Number | K160335 |
| Device Name: | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | St. Jude Medical 5050 Nathan Lane Plymouth, MN 55442 |
| Contact | Tamara Stanczak |
| Correspondent | Tamara Stanczak St. Jude Medical 5050 Nathan Lane Plymouth, MN 55442 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067025975 | K160335 | 000 |
| 05415067025968 | K160335 | 000 |
| 05415067024817 | K160335 | 000 |
| 05415067024800 | K160335 | 000 |