Device Classification Name |
Temporary Carotid Catheter For Embolic Capture
|
510(k) Number |
K081549 |
Device Name |
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM |
Applicant |
ABBOTT LABORATORIES |
3200 Lakeside Drive |
Santa Clara,
CA
95054
|
|
Applicant Contact |
VIRGINIA SINGER |
Correspondent |
ABBOTT LABORATORIES |
3200 Lakeside Drive |
Santa Clara,
CA
95054
|
|
Correspondent Contact |
VIRGINIA SINGER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/03/2008 |
Decision Date | 08/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|