The following data is part of a premarket notification filed by Covidien Llc with the FDA for Barrx Rfa Self Sizing Balloon Catheter.
| Device ID | K142364 |
| 510k Number | K142364 |
| Device Name: | Barrx RFA Self Sizing Balloon Catheter |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Rachel Silva |
| Correspondent | Rachel Silva Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2014-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521211599 | K142364 | 000 |