The following data is part of a premarket notification filed by Covidien Llc with the FDA for Cool-tip Rf Ablation System E Series.
| Device ID | K203150 |
| 510k Number | K203150 |
| Device Name: | Cool-tip RF Ablation System E Series |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien LLC 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Liron Bar Yaakov |
| Correspondent | Liron Bar Yaakov Covidien LLC 5920 Longbow Drive Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2022-02-25 |