FDA 510(k) Applications Submitted by Medtronic Neurosurgery

FDA 510(k) Number Submission Date Device Name Applicant
K123524 11/15/2012 MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY
DEN120017 12/21/2012 Medtronic DUET External Drainage and Monitoring System MEDTRONIC NEUROSURGERY
K242034 07/11/2024 Duet External Drainage and Monitoring System (EDMS) Medtronic Neurosurgery
K243676 11/27/2024 Duet External Drainage and Monitoring System (EDMS) Medtronic Neurosurgery
K013000 09/06/2001 MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 MEDTRONIC NEUROSURGERY
K040943 04/12/2004 MEDTRONIC PS MEDICAL STRATA VALVE MEDTRONIC NEUROSURGERY
K041992 07/23/2004 MEDTRONIC STRATAVARIUS MEDTRONIC NEUROSURGERY
K091312 05/04/2009 PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY
K063117 10/12/2006 MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY
K050044 01/10/2005 MEDTRONIC CLIP GUN KIT MEDTRONIC NEUROSURGERY
K110560 02/28/2011 MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER MEDTRONIC NEUROSURGERY
K060681 03/15/2006 MEDTRONIC PS MEDICAL STRATA TYPE VALUE MEDTRONIC NEUROSURGERY
K041000 04/19/2004 DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY
K082127 07/29/2008 STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 MEDTRONIC NEUROSURGERY
K062348 08/11/2006 TIMESH SELF DRILLING SCREW MEDTRONIC NEUROSURGERY
K042198 08/13/2004 PS MEDICAL NEUROSURGICAL IMPLANTS MEDTRONIC NEUROSURGERY
K052211 08/15/2005 DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY
K052386 08/31/2005 MEDTRONIC M2 MAGNET ADJUSTMENT TOOL MEDTRONIC NEUROSURGERY
K042465 09/13/2004 PS MEDICAL STRATA II VALVE MEDTRONIC NEUROSURGERY
K062821 09/20/2006 U-CLIP DEVICE MEDTRONIC NEUROSURGERY
K083076 10/16/2008 STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 MEDTRONIC NEUROSURGERY
K073139 11/07/2007 SMALL LUMEN PERITONEAL CATHETER MEDTRONIC NEUROSURGERY
K033850 12/11/2003 MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE MEDTRONIC NEUROSURGERY
K063836 12/26/2006 RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 MEDTRONIC NEUROSURGERY
K161370 05/17/2016 Durepair Dura Regeneration Matrix Medtronic Neurosurgery
K152700 09/21/2015 StrataMR Valves and Shunts MEDTRONIC NEUROSURGERY
K212641 08/20/2021 StrataMR II Valves and Shunts Medtronic Neurosurgery
K181622 06/20/2018 StrataMR guider tool Medtronic Neurosurgery


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