510(k) Report

Devices descending from K864676

6 later devices reach Heyer-Schulte Hermetic External CSF Drain. System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972994External CSF Drainage Management SystemsIntegra Neurocare, LLC19975—
+2K170599SureFlo EVD CatheterArkis Biosciences, Inc.201701
+2K030289Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830NIntegra Lifesciences Corp.20032—
+2K022638Neurorecovery Ventricular Catheter & Main Valve Assembly KitNeurorecovery, Inc.20020—
+3K121248Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM)…Moller Medical GmbH20131—
+4K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH20150—