Device Classification Name |
Balloon Aortic Valvuloplasty
|
510(k) Number |
K121083 |
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
|
|
Applicant Contact |
TIFFINI DIAGE |
Correspondent |
LOMA VISTA MEDICAL |
1307 SOUTH MARY AVE, STE 280 |
SUNNYVALE,
CA
94087
|
|
Correspondent Contact |
TIFFINI DIAGE |
Regulation Number | 870.1255
|
Classification Product Code |
|
Date Received | 04/10/2012 |
Decision Date | 10/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|