Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K161152 |
Device Name |
Navien Intracranial Support Catheter |
Applicant |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Applicant Contact |
Ingrid Takeuchi |
Correspondent |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Correspondent Contact |
Jennifer Correa |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 04/25/2016 |
Decision Date | 10/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|