The following data is part of a premarket notification filed by Brivant, Ltd. with the FDA for Victory Guidewire (32 Models).
Device ID | K120137 |
510k Number | K120137 |
Device Name: | VICTORY GUIDEWIRE (32 MODELS) |
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 | 2012-01-17 |
Decision Date | 2012-02-14 |
Summary: | summary |