Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K091254 |
Device Name |
THE CROSSER 14 OTW CATHETER, MODEL CRU014 |
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 | 04/29/2009 |
Decision Date | 05/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|