Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K231664 |
Device Name |
IRRAflow Active Fluid Exchange System (AFES) |
Applicant |
IRRAS USA Inc. |
11975 El Camino Real, Suite 304 |
San Diego,
CA
92130
|
|
Applicant Contact |
Jeanne S. Warner |
Correspondent |
IRRAS USA Inc. |
11975 El Camino Real, Suite 304 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Jeanne S. Warner |
Regulation Number | 882.5550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/07/2023 |
Decision Date | 10/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|