Device Classification Name |
introducer, catheter
|
510(k) Number |
K060902 |
Device Name |
STARCLOSE INTRODUCER SET MODEL- 1002 |
Applicant |
ABBOTT VASCULAR INC. |
400 Saginaw Drive |
Redwood City,
CA
94063
|
|
Applicant Contact |
KIM SMITH -SERVANCE |
Correspondent |
ABBOTT VASCULAR INC. |
400 Saginaw Drive |
Redwood City,
CA
94063
|
|
Correspondent Contact |
KIM SMITH -SERVANCE |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/03/2006 |
Decision Date | 07/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|