510(k) Report

Devices descending from K090342

4 later devices reach Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112156Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemMedos International SARL2011316
+2K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL20151—
+2K113526Codman Certas Programmable Valve SystemMedos International SARL2012016
+3K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp.20180—