The following data is part of a premarket notification filed by Brivant Limited with the FDA for Brivant Guidewire.
| Device ID | K060551 |
| 510k Number | K060551 |
| Device Name: | BRIVANT GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIVANT LIMITED 4 WESTLINK COMMERCIAL PARK Oranmore, Galway, IE |
| Contact | Tomas Furey |
| Correspondent | Tomas Furey BRIVANT LIMITED 4 WESTLINK COMMERCIAL PARK Oranmore, Galway, IE |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-02 |
| Decision Date | 2006-06-07 |
| Summary: | summary |