The following data is part of a premarket notification filed by Covidien with the FDA for Closurefast Radiofrequency Catheter.
| Device ID | K111887 |
| 510k Number | K111887 |
| Device Name: | CLOSUREFAST RADIOFREQUENCY CATHETER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Daniel Campion |
| Correspondent | Daniel Campion COVIDIEN 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 | 2011-07-01 |
| Decision Date | 2011-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169862944 | K111887 | 000 |
| 00643169862937 | K111887 | 000 |
| 10884521174924 | K111887 | 000 |
| 10884521058071 | K111887 | 000 |
| 10884521058057 | K111887 | 000 |
| 00763000702298 | K111887 | 000 |