|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
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monitorr icp external drainage and monitoring system, limitorr volume limiting external csf drainage system
|
Integra Lifesciences Corporation
|
K191684 |
10/11/2019
|
horizontal-vertical lumbar valve systems, spetzler lumbar peritoneal shunt systems
|
INTEGRA LIFESCIENCES CORPORATION
|
K161992 |
09/22/2016
|
bundled neurological shunts and accessories product families labeling modification to support mr conditional labeling
|
INTEGRA LIFESCIENCES CORPORATION
|
K153041 |
03/14/2016
|
integra dp valve systems (including burr hole reservoirs and stainless steel connectors), gravity compensating accessory
|
INTEGRA LIFESCIENCES CORPORATION
|
K152897 |
03/04/2016
|
integra flow regulating valve systems osv ii models and integra flow regulating valve low flow models
|
INTEGRA LIFESCIENCES CORPORATION
|
K140722 |
01/06/2015
|
horizontal-vertical lumbar valve and spetzler lumbar peritoneal shunt systems
|
INTEGRA LIFESCIENCES CORPORATION
|
K101381 |
07/07/2011
|
osv ii low flow low pro valve
|
INTEGRA LIFESCIENCES CORPORATION
|
K093968 |
01/22/2010
|
limitorr volume limiting external csf drainage and monitoring system, models ins9020, ins9030
|
INTEGRA LIFESCIENCES CORPORATION
|
K072929 |
12/07/2007
|
monitorr icp external drainage and monitoring systems
|
INTEGRA LIFESCIENCES CORPORATION
|
K062599 |
09/27/2006
|
accudrain external csf drainage system
|
INTEGRA LIFESCIENCES CORPORATION
|
K042825 |
12/21/2004
|