Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K080849 |
Device Name |
MICROSHEATH LP AND LP-AT |
Applicant |
FLOWCARDIA, INC. |
745 N. PASTORIA AVE. |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
Dustin Michaels |
Correspondent |
FLOWCARDIA, INC. |
745 N. PASTORIA AVE. |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
Dustin Michaels |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/26/2008 |
Decision Date | 07/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|