The following data is part of a premarket notification filed by Covidien Llc with the FDA for Emprint Ablation System With Thermosphere Technology, Emprint Sx Ablation Platform With Thermosphere Technology.
| Device ID | K193232 |
| 510k Number | K193232 |
| Device Name: | Emprint Ablation System With Thermosphere Technology, Emprint SX Ablation Platform With Thermosphere Technology |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Hilla Debby |
| Correspondent | Hilla Debby Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-02-13 |