Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K190338 |
Device Name |
046 Zenith Flex |
Applicant |
InNeuroCo, Inc |
4635 NW 103rd Avenue |
Sunrise,
FL
33351
|
|
Applicant Contact |
Marc Litzenberg |
Correspondent |
InNeuroCo |
4635 NW 103rd Avenue |
Sunrise,
FL
33351
|
|
Correspondent Contact |
Marianne Grunwaldt |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/14/2019 |
Decision Date | 08/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|