The following data is part of a premarket notification filed by Coviden Llc with the FDA for Emprint Sx Ablation Platform And Accessories.
| Device ID | K171358 |
| 510k Number | K171358 |
| Device Name: | Emprint SX Ablation Platform And Accessories |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Coviden Llc 5920 Longbow Dr. Boulder, CO 80301 |
| Contact | Patti Arndt |
| Correspondent | Patti Arndt Coviden Llc 5920 Longbow Dr. Boulder, CO 80301 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-09-01 |
| Summary: | summary |