Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K163233 |
Device Name |
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter |
Applicant |
MIVI NEUROSCIENCE, INC |
6545 City West Parkway |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Randy LaBounty |
Correspondent |
PHILBROOK CORPORATION |
8701 E. VISTA BONITA DR., SUITE 210 |
Scottsdale,
AZ
85255
|
|
Correspondent Contact |
Avi Roop |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/17/2016 |
Decision Date | 04/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|