Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K121694 |
Device Name |
IMAGER II ANGIOGRAPHIC CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
HOLLY RAMIREZ |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
HOLLY RAMIREZ |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 09/14/2012 |
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
|
|
|