Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K103751 |
Device Name |
MUSTANG BALLOON DILATATION CATHETERS |
Applicant |
BOSTON SCIENTIFIC |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
ANNE V ROSSI |
Correspondent |
BOSTON SCIENTIFIC |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
ANNE V ROSSI |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/23/2010 |
Decision Date | 03/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|