Device Classification Name |
pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
|
510(k) Number |
K122367 |
Device Name |
BARD PTV DILATATION CATHETER |
Applicant |
C.R. BARD, INC. |
1625 W. THIRD STREET |
TEMPE,
AZ
85281
|
|
Applicant Contact |
ERIN FOX |
Correspondent |
C.R. BARD, INC. |
1625 W. THIRD STREET |
TEMPE,
AZ
85281
|
|
Correspondent Contact |
ERIN FOX |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/06/2012 |
Decision Date | 11/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|