Atlas FDA

PS MEDICAL STRATA II VALVE

FDA 510(k) clearance K042465 · decided 2004-10-19

Clearance details

K-number
K042465
Device name
PS MEDICAL STRATA II VALVE
Applicant
Medtronic Neurosurgery
Decision
Substantially Equivalent
Date received
2004-09-13
Decision date
2004-10-19
Days to decision
36 days
Clearance type
Special
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
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Cat recall (Z-1121-2017)Medtronic Neurosurgery2017-02-02
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assembli recall (Z-0399-2014)Medtronic Neurosurgery2013-11-26