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 |
10884521581753 | K130623 | 000 |