510(k) Report

Devices descending from K042359

2 later devices reach Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252514Evac-MriPhasor Health, LLC20250—
+1K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc.20240—