Device Classification Name |
neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
|
510(k) Number |
K181060 |
Device Name |
Solitaire 2 and Solitaire Platinum Revascularization Device |
Applicant |
Medtronic Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Applicant Contact |
Amnon Talmor |
Correspondent |
Medtronic Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Correspondent Contact |
Amnon Talmor |
Regulation Number | 882.5600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/23/2018 |
Decision Date | 08/24/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|