Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K033742 |
Device Name |
BOSTON SCIENTIFIC V-18 CONTROL WIRE |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
DEBORAH THOMAS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
DEBORAH THOMAS |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/28/2003 |
Decision Date | 01/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|