Device Classification Name |
catheter, intravascular occluding, temporary
|
510(k) Number |
K132990 |
Device Name |
OCCLUSION BALLOON CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
DIANE NELSON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
DIANE NELSON |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 09/24/2013 |
Decision Date | 10/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|