510(k) Report

Devices descending from K153347

5 later devices reach Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+1K182073BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A.20192—
+1K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…Codman & Shurtleff, Inc.201701
+2K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.20211—
+3K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.20240—