Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K070126 |
Device Name |
OCCLUSION BALLOON CATHETER |
Applicant |
SENTREHEART INC. |
2468 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
LINDA GUTHRIE |
Correspondent |
SENTREHEART INC. |
2468 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
LINDA GUTHRIE |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/16/2007 |
Decision Date | 02/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|