The following data is part of a premarket notification filed by Covidien Llc with the FDA for Emprint Ablation System.
| Device ID | K133821 |
| 510k Number | K133821 |
| Device Name: | EMPRINT ABLATION SYSTEM |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Covidien LLC 15 HAMPSHIRE ST Mansfield, MA 02048 |
| Contact | Heather V Nigro |
| Correspondent | Heather V Nigro Covidien LLC 15 HAMPSHIRE ST Mansfield, MA 02048 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-04-28 |
| Summary: | summary |