The following data is part of a premarket notification filed by Covidien Llc with the FDA for Emprint Ablation System.
| Device ID | K163105 |
| 510k Number | K163105 |
| Device Name: | Emprint Ablation System |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | COVIDIEN LLC 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Patti Arndt |
| Correspondent | Patti Arndt COVIDIEN LLC 5920 LONGBOW DR. 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 | 2016-11-07 |
| Decision Date | 2016-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521706606 | K163105 | 000 |
| 10884521706590 | K163105 | 000 |
| 10884521706583 | K163105 | 000 |
| 10884521806566 | K163105 | 000 |
| 10884521806559 | K163105 | 000 |
| 10884521806542 | K163105 | 000 |