Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K152700 |
Device Name |
StrataMR Valves and Shunts |
Applicant |
MEDTRONIC NEUROSURGERY |
125 CREMONA DRIVE |
GOLETA,
CA
93117
|
|
Applicant Contact |
Micah Schloss |
Correspondent |
MEDTRONIC NEUROSURGERY |
125 CREMONA DRIVE |
GOLETA,
CA
93117
|
|
Correspondent Contact |
Deep Pal |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 09/21/2015 |
Decision Date | 04/07/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|