FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VDRIVE W/V-SONO
K Number: K122659
·
Decision Jul 26, 2013
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
28
Review Days
329
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Basic Information
- Device Name
- VDRIVE W/V-SONO
- K Number
- K122659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stereotaxis, Inc.
- Date Received
- August 31, 2012
- Decision Date
- July 26, 2013
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Stereotaxis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253473 | Synchrony | Apr 1, 2026 | Substantially Equivalent |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Nov 6, 2025 | Substantially Equivalent |
| K250590 | MAGiC Sweep EP Mapping Catheter | Jul 23, 2025 | Substantially Equivalent |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Mar 5, 2020 | Substantially Equivalent |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Oct 30, 2019 | Substantially Equivalent |
| K183027 | Steerable catheter control system | Sep 6, 2019 | Substantially Equivalent |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Jun 17, 2015 | Substantially Equivalent |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Dec 18, 2014 | Substantially Equivalent |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Sep 3, 2014 | Substantially Equivalent |
| K133396 | VDRIVE WITH V-SONO | Feb 6, 2014 | Substantially Equivalent |