Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K111295 |
Device Name |
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS |
Applicant |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
MARK MURPHY |
Correspondent |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
MARK MURPHY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/10/2011 |
Decision Date | 05/31/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|