The following data is part of a premarket notification filed by Brivant, Ltd. with the FDA for Cruiser 18 Guidewire.
| Device ID | K102211 |
| 510k Number | K102211 |
| Device Name: | CRUISER 18 GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIVANT, LTD. PARKMORE WEST BUSINESS PARK Galway, County Galway, IE |
| Contact | Tomas Furey |
| Correspondent | Tomas Furey BRIVANT, LTD. PARKMORE WEST BUSINESS PARK Galway, County Galway, IE |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-05 |
| Decision Date | 2010-09-03 |
| Summary: | summary |