Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K162350 |
Device Name |
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation |
Applicant |
Boston Scientific Corporation |
One Scimed Place |
Maple Grove,
MN
55311 -1566
|
|
Applicant Contact |
Ka Zoua Xiong |
Correspondent |
Boston Scientific Corporation |
One Scimed Place |
Maple Grove,
MN
55311 -1566
|
|
Correspondent Contact |
Ka Zoua Xiong |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/23/2016 |
Decision Date | 11/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|