Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K180715 |
Device Name |
React 68 Catheter |
Applicant |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Applicant Contact |
Ryan Kenney |
Correspondent |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Correspondent Contact |
Ryan Kenney |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/19/2018 |
Decision Date | 07/04/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|