The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Nitinol Thermocouple (tcn) Electrode.
| Device ID | K183177 |
| 510k Number | K183177 |
| Device Name: | Nitinol Thermocouple (TCN) Electrode |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Boston Scientific Corporation 25155 Rye Canyon Loop Valencia, CA 91355 |
| Contact | Adele Shoustal |
| Correspondent | Adele Shoustal Boston Scientific Corporation 25155 Rye Canyon Loop Valencia, CA 91355 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-03-08 |
| Summary: | summary |