510(k) Report

Devices descending from K853365

3 later devices reach H-H Fifth Ventricle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa20250—
+1K081942Neurocath AGVygon Neuro20081—
+2K170599SureFlo EVD CatheterArkis Biosciences, Inc.201701