FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VDRIVE WITH V-LOOP/ VDRIVE DUO
K Number: K140804
·
Decision Sep 3, 2014
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
30
Applicant Total
22
Review Days
156
Basic Information
- Device Name
- VDRIVE WITH V-LOOP/ VDRIVE DUO
- K Number
- K140804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STEREOTAXIS, INC.
- Date Received
- March 31, 2014
- Decision Date
- September 3, 2014
- Product Code
- DXX
- 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 |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Other Clearances by STEREOTAXIS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K133396 | VDRIVE WITH V-SONO | Feb 6, 2014 | Substantially Equivalent |
| K122659 | VDRIVE W/V-SONO | Jul 26, 2013 | Substantially Equivalent |
| K093092 | ODYSSEY WORKSTATION | Jan 21, 2010 | Substantially Equivalent |
| K080637 | POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS | Aug 12, 2008 | Substantially Equivalent |
| K072371 | ODYSSEY WORKSTATION | Nov 14, 2007 | Substantially Equivalent |
| K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) | Aug 24, 2007 | Substantially Equivalent |
| K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | Oct 19, 2006 | Substantially Equivalent |
| K042850 | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) | Aug 9, 2006 | Substantially Equivalent |