Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K011906 |
Device Name |
BACK-UP MEIER GUIDEWIRE |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
JODI LYNN GREENIZEN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
JODI LYNN GREENIZEN |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 06/19/2001 |
Decision Date | 08/13/2001 |
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
|
|
|