The following data is part of a premarket notification filed by Brivant, Ltd. with the FDA for Cps Courier Guidewire.
Device ID | K073082 |
510k Number | K073082 |
Device Name: | CPS COURIER 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 | 2007-11-01 |
Decision Date | 2008-01-09 |
Summary: | summary |