| Device Classification Name |
system, balloon, intra-aortic and control
|
|---|
| 510(K) Number |
K120868 |
|---|
| Models |
0684-00-0294-XX,
0684-00-0295-XX
|
| Device Name |
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER |
|---|
| Applicant |
| DATASCOPE CORP., CARDIAC ASSIST DIVISION |
| 15 law dr. |
|
fairfield,
NJ
07004 0011
|
|
| Contact |
helder a sousa |
| Regulation Number | 870.3535
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/22/2012 |
|---|
| Decision Date | 04/20/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
