Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K161853 |
Device Name |
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System |
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 | 07/06/2016 |
Decision Date | 02/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01885468
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|