Atlas FDA

StrataMR Valves and Shunts

FDA 510(k) clearance K152700 · decided 2016-04-07

Clearance details

K-number
K152700
Device name
StrataMR Valves and Shunts
Applicant
Medtronic Neurosurgery
Decision
Substantially Equivalent
Date received
2015-09-21
Decision date
2016-04-07
Days to decision
199 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Goleta, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cer recall (Z-1702-2017)Medtronic Neurosurgery2017-04-07