The following data is part of a premarket notification filed by Covidien Llc with the FDA for Barrx Sb Rfa Endoscopic Catheter.
| Device ID | K173559 |
| 510k Number | K173559 |
| Device Name: | Barrx SB RFA Endoscopic Catheter |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Saket Bhatt |
| Correspondent | Saket Bhatt Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-17 |
| Decision Date | 2018-01-18 |
| Summary: | summary |