510(k) Report

Devices descending from K861377

34 later devices reach Standard/Pediatric Cordis Hydrocephalus Valves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel…Integra LifeSciences Corporation20160—
+1K020728Miethke Shunt SystemAesculap, Inc.200221
+1K992465Sophy SU8 Pressure Adjustable ValveSophysa SA200029—
+2K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.20240—
+2K200950Ventricular CatheterAesculap, Inc.20200—
+2K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA20029—
+2K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical200225—
+3K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery200672
+3K052386Medtronic M2 Magnet Adjustment ToolMedtronic Neurosurgery20050—
+3K041992Medtronic StratavariusMedtronic Neurosurgery20050—
+3K042465PS Medical Strata II ValveMedtronic Neurosurgery2004194
+3K042198PS Medical Neurosurgical ImplantsMedtronic Neurosurgery20040—
+3K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA20048—
+3K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery2004232
+4K152700StrataMR Valves and ShuntsMedtronic Neurosurgery20162Class I
+4K110206Aesculap- Meithke Shunt SystemAesculap, Inc.201132
+4K112156Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemMedos International SARL2011316
+4K091312PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery20091—
+4K083076Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836Medtronic Neurosurgery200801
+4K082127Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635Medtronic Neurosurgery200811
+4K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.20076—
+4K042481Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400Sophysa SA20047—
+5K212641StrataMR II Valves and ShuntsMedtronic Neurosurgery20210—
+5K181622StrataMR guider toolMedtronic Neurosurgery20180—
+5K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…Aesculap, Inc.201711
+5K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc.20152—
+5K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL20151—
+5K123524Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery201301
+5K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.201222
+5K113526Codman Certas Programmable Valve SystemMedos International SARL2012016
+5K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc.201045
+5K091328Siphonx Gravitational Antisiphon DeviceSophysa SA20100—
+6K192266M. Blue Adjustable Shunt SystemAesculap, Inc.20190—
+6K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp.20180—