Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K210230 |
Device Name |
Phenom Catheters |
Applicant |
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
lrvine,
CA
92618
|
|
Applicant Contact |
Prerana Gurubasavaraj |
Correspondent |
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular |
9775 Toledo Way |
lrvine,
CA
92618
|
|
Correspondent Contact |
Prerana Gurubasavaraj |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/28/2021 |
Decision Date | 02/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|