510(k) Report

Devices descending from K992465

29 later devices reach Sophy SU8 Pressure Adjustable Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA20029—
+1K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical200225—
+2K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery200672
+2K052386Medtronic M2 Magnet Adjustment ToolMedtronic Neurosurgery20050—
+2K041992Medtronic StratavariusMedtronic Neurosurgery20050—
+2K042465PS Medical Strata II ValveMedtronic Neurosurgery2004194
+2K042198PS Medical Neurosurgical ImplantsMedtronic Neurosurgery20040—
+2K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA20048—
+2K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery2004232
+3K152700StrataMR Valves and ShuntsMedtronic Neurosurgery20162Class I
+3K110206Aesculap- Meithke Shunt SystemAesculap, Inc.201132
+3K112156Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemMedos International SARL2011316
+3K091312PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery20091—
+3K083076Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836Medtronic Neurosurgery200801
+3K082127Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635Medtronic Neurosurgery200811
+3K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.20076—
+3K042481Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400Sophysa SA20047—
+4K212641StrataMR II Valves and ShuntsMedtronic Neurosurgery20210—
+4K181622StrataMR guider toolMedtronic Neurosurgery20180—
+4K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…Aesculap, Inc.201711
+4K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc.20152—
+4K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL20151—
+4K123524Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery201301
+4K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.201222
+4K113526Codman Certas Programmable Valve SystemMedos International SARL2012016
+4K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc.201045
+4K091328Siphonx Gravitational Antisiphon DeviceSophysa SA20100—
+5K192266M. Blue Adjustable Shunt SystemAesculap, Inc.20190—
+5K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp.20180—