| Device Classification Name |
system, x-ray, tomography, computed
|
|---|
| 510(K) Number |
K122106 |
|---|
| Models |
INS-0320,
INS-0330,
INS-0340, INS-0350, INS-0360,
SYS-2000
|
| Device Name |
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE |
|---|
| Applicant |
| VERN MEDICAL TECHNOLOGIES |
| 1908 innerbelt business center drive |
|
st. louis,
MO
63114
|
|
| Contact |
scott wrightstone |
| Regulation Number | 892.1750
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/17/2012 |
|---|
| Decision Date | 12/21/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
