The following data is part of a premarket notification filed by Brivant, Ltd. with the FDA for Charter Guidewire.
| Device ID | K122856 |
| 510k Number | K122856 |
| Device Name: | CHARTER GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIVANT, LTD. PARKMORE WEST BUSINESS PARK Galway, IE Ei |
| Contact | Kenneth Walsh |
| Correspondent | Kenneth Walsh BRIVANT, LTD. PARKMORE WEST BUSINESS PARK Galway, IE Ei |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2012-10-17 |
| Summary: | summary |