510(k) Report

Devices descending from K915546

3 later devices reach PS Medical Ventriculostomy Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)…Medical Designs, LLC200421
+2K252514Evac-MriPhasor Health, LLC20250—
+2K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc.20240—