510(k) Report

Devices descending from K002765

20 later devices reach Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141869Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated20140—
+1K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+1K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp.201305
+1K041838MPS (or MPS-T)Innerspace, Inc.20053—
+1K040235Licox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation2004212
+1K032337Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated20031—
+1K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20023—
+1K020558Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences20023—
+1K013005Act 11 MP Ventricular CatheterInnerspace, Inc.20024—
+2K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+2K171666MPR2 logO DATALOGGERRaumedic AG20170—
+2K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+2K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20081—
+2K072379MPS Oxiport and MPS Oxiport PlusInnerspace, Inc.20082—
+2K053244Licox IT2 Complete Brain Tunneling Probe KitIntegra Lifesciences Corp.200601
+2K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20062—
+3K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+3K102077Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20110—
+3K083378SynergyInnerspace, Inc.20091—
+4K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.20160—