Device Classification Name |
Catheter, Thrombus Retriever
|
510(k) Number |
K113455 |
Device Name |
SOLITAIRE FR REVASCULARIZATION DEVICE |
Applicant |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Applicant Contact |
Laura Heaton |
Correspondent |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Correspondent Contact |
Laura Heaton |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/21/2011 |
Decision Date | 03/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01054560
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|