Device Classification Name |
device, vascular, for promoting embolization
|
510(k) Number |
K150964 |
Device Name |
MReye Flipper Detachable Embolization Coil and Delivery System |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47402
|
|
Applicant Contact |
Nozomi Yagi |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47402
|
|
Correspondent Contact |
Nozomi Yagi |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 04/10/2015 |
Decision Date | 12/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|