Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K110479 |
Device Name |
ACUITY WHISPER VIEW GUIDE WIRES |
Applicant |
BOSTON SCIENTIFIC CORP. |
4100 HAMLINE AVE NORTH |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
KIRSTIN JOHNSTON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
4100 HAMLINE AVE NORTH |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
KIRSTIN JOHNSTON |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 02/18/2011 |
Decision Date | 04/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|