Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K071309 |
Device Name |
BLUE MAX BALLOON DILATATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
TWO SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
KARI CHRISTIANSON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
TWO SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
KARI CHRISTIANSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/09/2007 |
Decision Date | 07/13/2007 |
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
|
|
|