Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K133310 |
Device Name |
AXIUM DETACHABLE COIL SYSTEM |
Applicant |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Applicant Contact |
ANGELA LAMPREY |
Correspondent |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Correspondent Contact |
ANGELA LAMPREY |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/28/2013 |
Decision Date | 01/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|