| Device Classification Name |
balloon aortic valvuloplasty
|
|---|
| 510(K) Number |
K121083 |
|---|
| Model |
2045-11, 2245-12, 2445-12
|
| Device Name |
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA |
|---|
| Applicant |
| LOMA VISTA MEDICAL |
| 1307 south mary ave, ste 280 |
|
sunnyvale,
CA
94087
|
|
| Contact |
tiffini diage |
| Regulation Number | 870.1250
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/10/2012 |
|---|
| Decision Date | 10/11/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
