510(k) Report

Devices descending from K973774

40 later devices reach Codman Hakim Micro Precision Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.201731
+1K102961Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors…Codman & Shurtleff, Inc.20110—
+1K091346Codman Hakim Micro II ValveCodman & Shurtleff, Inc.20090—
+1K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20028—
+1K980778Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc.199838—
+2K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation20241—
+2K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation20220—
+2K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc.20124—
+2K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.20076—
+2K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20065—
+2K053107Codman Hakim Programmable Valve W/WO SiphonguardCodman & Shurtleff, Inc.20060—
+2K020728Miethke Shunt SystemAesculap, Inc.200221
+2K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical200225—
+3K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation20250—
+3K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.20240—
+3K200950Ventricular CatheterAesculap, Inc.20200—
+3K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…Aesculap, Inc.201711
+3K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc.20152—
+3K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.201222
+3K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc.201045
+3K091328Siphonx Gravitational Antisiphon DeviceSophysa SA20100—
+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—
+3K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery2004232
+4K192266M. Blue Adjustable Shunt SystemAesculap, Inc.20190—
+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
+5K212641StrataMR II Valves and ShuntsMedtronic Neurosurgery20210—
+5K181622StrataMR guider toolMedtronic Neurosurgery20180—
+5K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL20151—
+5K123524Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery201301
+5K113526Codman Certas Programmable Valve SystemMedos International SARL2012016
+6K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp.20180—