Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K200950 |
Device Name |
Ventricular Catheter |
Applicant |
Aesculap, Inc. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
Kathy A. Racosky |
Correspondent |
Aesculap, Inc. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
Kathy A. Racosky |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 04/09/2020 |
Decision Date | 05/08/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|