Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K201690 |
Device Name |
Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire |
Applicant |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Applicant Contact |
Prerana Gurubasavaraj |
Correspondent |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
Irvine,
CA
92618
|
|
Correspondent Contact |
Prerana Gurubasavaraj |
Regulation Number | 870.1330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/22/2020 |
Decision Date | 07/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|