Device Classification Name |
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
|
510(k) Number |
K162539 |
Device Name |
Solitaire 2 Revascularization Device |
Applicant |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Applicant Contact |
JENNIFER CORREA |
Correspondent |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JENNIFER CORREA |
Regulation Number | 882.5600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/12/2016 |
Decision Date | 11/10/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01657461
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|