Device Classification Name |
aspiration thrombectomy catheter
|
510(k) Number |
K051880 |
Device Name |
RIO ASPIRATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
2011 STIERLIN CT. |
MOUNTAIN VIEW,
CA
94043 -4655
|
|
Applicant Contact |
CATHERINE A PETERS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2011 STIERLIN CT. |
MOUNTAIN VIEW,
CA
94043 -4655
|
|
Correspondent Contact |
CATHERINE A PETERS |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 07/11/2005 |
Decision Date | 01/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|