Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K051580 |
Device Name |
VP SHEATH |
Applicant |
FLOWCARDIA, INC. |
745 N. PASTORIA AVE. |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
RICHARD SPANO |
Correspondent |
FLOWCARDIA, INC. |
745 N. PASTORIA AVE. |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
RICHARD SPANO |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/15/2005 |
Decision Date | 10/31/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|