Device Classification Name |
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
|
510(k) Number |
K193576 |
Device Name |
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) |
Applicant |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Applicant Contact |
Helen Chow |
Correspondent |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Correspondent Contact |
Jennifer L Correa |
Regulation Number | 882.5600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/23/2019 |
Decision Date | 11/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02239640
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|