The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Advisor Hd Grid Mapping Catheter, Sensor Enabled.
| Device ID | K172393 |
| 510k Number | K172393 |
| Device Name: | Advisor HD Grid Mapping Catheter, Sensor Enabled |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | St. Jude Medical, Inc. 5050 Nathan Lane N Plymouth, MN 55442 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether St. Jude Medical, Inc. 5050 Nathan Lane N Plymouth, MN 55442 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2018-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067028198 | K172393 | 000 |