Vdrive W/V-Sono
FDA 510(k) K122659 · Stereotaxis, Inc.
510(k) numberK122659
Submission
- Device name
- Vdrive W/V-Sono
- Applicant
- Stereotaxis, Inc.
St. Louis, MO, US - Received
- August 31, 2012
- Decision date
- July 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K262744 | GenesisX RMNDXX · Special | 08/27/2026SE |
| K253473 | SynchronyDQK · Traditional | 04/01/2026SE |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS)DXX · Traditional | 11/06/2025SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | 07/23/2025SE |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional | 03/05/2020SE |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special | 10/30/2019SE |
| K183027 | Steerable catheter control systemPJB · Traditional | 09/06/2019SE |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional | 06/17/2015SE |
| K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-CasDXX · Traditional | 12/18/2014SE |
| K140804 | Vdrive with V-Loop/ Vdrive DuoDXX · Traditional | 09/03/2014SE |
Questions and answers
When was Vdrive W/V-Sono cleared by the FDA?
Vdrive W/V-Sono (K122659) received a 510(k) decision of Substantially Equivalent on July 26, 2013, 329 days after the submission was received.
What is the product code of K122659?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.