The following data is part of a premarket notification filed by Covidien Llc with the FDA for Barrx Channel Rfa Endoscopic Catheter.
| Device ID | K130623 |
| 510k Number | K130623 |
| Device Name: | BARRX CHANNEL RFA ENDOSCOPIC CATHETER |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Covidien LLC 15 HAMPSHIRE ST Mansfield, MA 02048 |
| Contact | Richelle Hover |
| Correspondent | Richelle Hover Covidien LLC 15 HAMPSHIRE ST Mansfield, MA 02048 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521176621 | K130623 | 000 |
| 20884521176611 | K130623 | 000 |