510(k) Report

Devices descending from K974739

42 later devices reach Hakim Programmable Valve System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.201731
+1K152152Codman Certas Plus Programmable ValveMedos International SARL20152—
+1K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc.20124—
+1K112156Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemMedos International SARL2011316
+1K091346Codman Hakim Micro II ValveCodman & Shurtleff, Inc.20090—
+1K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20065—
+1K053107Codman Hakim Programmable Valve W/WO SiphonguardCodman & Shurtleff, Inc.20060—
+1K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20028—
+1K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical200225—
+1K992465Sophy SU8 Pressure Adjustable ValveSophysa SA200029—
+2K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation20241—
+2K223330Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation202301
+2K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation20220—
+2K182265CodMan Certas Plus Programmable ValveIntegra Lifesciences Corp.20181—
+2K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL20151—
+2K113526Codman Certas Programmable Valve SystemMedos International SARL2012016
+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—
+2K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery2004232
+2K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA20029—
+3K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation20250—
+3K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp.20180—
+3K152700StrataMR Valves and ShuntsMedtronic Neurosurgery20162Class I
+3K110206Aesculap- Meithke Shunt SystemAesculap, Inc.201132
+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—
+3K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA20048—
+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—
+4K123524Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery201301
+4K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.201222
+4K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc.201045
+4K091328Siphonx Gravitational Antisiphon DeviceSophysa SA20100—
+4K042481Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400Sophysa SA20047—
+5K192266M. Blue Adjustable Shunt SystemAesculap, Inc.20190—