Victory Guidewire (32 Models)
FDA 510(k) K120137 · Brivant, Ltd.
510(k) numberK120137
Submission
- Device name
- Victory Guidewire (32 Models)
- Applicant
- Brivant, Ltd.
Galway, IE - Received
- January 17, 2012
- Decision date
- February 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code DQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141831 | Hydraview GuidewireDQX · Traditional | 09/04/2014SE |
| K122856 | Charter GuidewireDQX · Special | 10/17/2012SE |
| K103377 | Charter Guidewire Model 45-281, 45-282, 45-283DQX · Special | 05/18/2011SE |
| K102211 | Cruiser 18 GuidewireDQX · Special | 09/03/2010SE |
| K093515 | 3 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2…DQX · Traditional | 02/16/2010SE |
| K083094 | Streamer Polymer GuidewireDQX · Traditional | 07/07/2009SE |
| K073082 | CPS Courier GuidewireDQX · Special | 01/09/2008SE |
| K060551 | Brivant GuidewireDQX · Traditional | 06/07/2006SE |
Questions and answers
When was Victory Guidewire (32 Models) cleared by the FDA?
Victory Guidewire (32 Models) (K120137) received a 510(k) decision of Substantially Equivalent on February 14, 2012, 28 days after the submission was received.
What is the product code of K120137?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.