Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- K251598Intellidrop2Cleared 510(K)
- K250636Sophy Mini Monopressure Valve (SM1)2Cleared 510(K)
- K252514EVAC-MRI2Cleared 510(K)
- K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology2Cleared 510(K)
- K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)2Cleared 510(K)
- K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters2Cleared 510(K)
- K243205EVAC2Cleared 510(K)
- K243676Duet External Drainage and Monitoring System (EDMS)2Cleared 510(K)
- K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set2Cleared 510(K)
- K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)2Cleared 510(K)
- K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter2Cleared 510(K)
- K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set2Cleared 510(K)
- K231664IRRAflow Active Fluid Exchange System (AFES)2Cleared 510(K)
- K221694External Drainage System2Cleared 510(K)
- K222422Polaris Valve Electronic Reading Instrument2Cleared 510(K)
- K223330Certas Plus Programmable Valves2Cleared 510(K)
- K223603Reflow System Mini and ReFlow Mini Flusher2Cleared 510(K)
- K222471IRRAflow Active Fluid Exchange System (AFES)2Cleared 510(K)
- K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves2Cleared 510(K)
- K221918ReFlow System Mini2Cleared 510(K)
- K212641StrataMR II Valves and Shunts2Cleared 510(K)
- K200950Ventricular Catheter2Cleared 510(K)
- K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit2Cleared 510(K)
- K192266M. Blue Adjustable Shunt System2Cleared 510(K)
- K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit2Cleared 510(K)
- K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System2Cleared 510(K)
- K190174Miethke Shunt System GAV 2.0 and SA 2.0 Valves2Cleared 510(K)
- K182265CodMan Certas Plus Programmable Valve2Cleared 510(K)
- K181902Codman Certas Plus Electronic Tool Kit2Cleared 510(K)
- K181622StrataMR guider tool2Cleared 510(K)
- K171880IRRAflow CNS System2Cleared 510(K)
- K181301Smart External Drain (SED) System2Cleared 510(K)
- K172035EKOS ultrasound EVD Device, EVD Control Unit2Cleared 510(K)
- K172759Smart External Drain (SED) System2Cleared 510(K)
- K172006Alivio Ventricular Catheter and Flusher System (Alivio System)2Cleared 510(K)
- K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag2Cleared 510(K)
- K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)2Cleared 510(K)
- K170599SureFlo EVD Catheter2Cleared 510(K)
- K171586Smart External Drain (SED) System2Cleared 510(K)
- K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System2Cleared 510(K)
- K162437Codman EDS3 CSF External Drainage System2Cleared 510(K)
- K161605Smart External Drain (SED) System2Cleared 510(K)
- K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems2Cleared 510(K)
- K152700StrataMR Valves and Shunts2Cleared 510(K)
- K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling2Cleared 510(K)
- K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory2Cleared 510(K)
- K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm2Cleared 510(K)
- K152152Codman Certas Plus Programmable Valve2Cleared 510(K)
- K141687AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM2Cleared 510(K)
- K141227POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX2Cleared 510(K)
- K143111Codman Certas Plus Programmable Valve; Codman Certas Toll Kit2Cleared 510(K)
- K140722INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS2Cleared 510(K)
- K121248LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC2Cleared 510(K)
- K123554SHUNTCHECK2Cleared 510(K)
- K123524MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM2Cleared 510(K)
- K122118HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM2Cleared 510(K)
- K120559AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM2Cleared 510(K)
- K113526CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM2Cleared 510(K)
- K110560MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER2Cleared 510(K)
- K110206AESCULAP- MEITHKE SHUNT SYSTEM2Cleared 510(K)
- K112156CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM2Cleared 510(K)
- K101381HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS2Cleared 510(K)
- K110751CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER2Cleared 510(K)
- K102961HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM2Cleared 510(K)
- K102589CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER2Cleared 510(K)
- K103003AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM2Cleared 510(K)
- K093968OSV II LOW FLOW LOW PRO VALVE2Cleared 510(K)
- K091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICE2Cleared 510(K)
- K092395OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM2Cleared 510(K)
- K091312PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM2Cleared 510(K)
- K090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-4002Cleared 510(K)
- K091346CODMAN HAKIM MICRO II VALVE2Cleared 510(K)
- K090348CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET2Cleared 510(K)
- K083076STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 468362Cleared 510(K)
- K081773OSV II2Cleared 510(K)
- K082127STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 466352Cleared 510(K)
- K081942NEUROCATH AG2Cleared 510(K)
- K080168SHUNTCHECK - CSF SHUNT FLOW DETECTOR2Cleared 510(K)
- K073139SMALL LUMEN PERITONEAL CATHETER2Cleared 510(K)
- K072929LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS90302Cleared 510(K)
- K063836RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-417152Cleared 510(K)
- K062009AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T2Cleared 510(K)
- K061876CODMAN VPV SYSTEM, MODEL 82-31922Cleared 510(K)
- K061568CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-17382Cleared 510(K)
- K062599MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS2Cleared 510(K)
- K060681MEDTRONIC PS MEDICAL STRATA TYPE VALUE2Cleared 510(K)
- K053350MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS2Cleared 510(K)
- K053107CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD2Cleared 510(K)
- K052386MEDTRONIC M2 MAGNET ADJUSTMENT TOOL2Cleared 510(K)
- K050739CODMAN VPV SYSTEM, MODEL 82-31922Cleared 510(K)
- K041992MEDTRONIC STRATAVARIUS2Cleared 510(K)
- K042825ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM2Cleared 510(K)
- K042481POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-4002Cleared 510(K)
- K042359SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL2Cleared 510(K)
- K040021SHUNTCHECK (PROMETHEUS 1)2Cleared 510(K)
- K042465PS MEDICAL STRATA II VALVE2Cleared 510(K)
- K042558EQUI-FLOW VALVE AND SHUNT SYSTEM2Cleared 510(K)
- K042198PS MEDICAL NEUROSURGICAL IMPLANTS2Cleared 510(K)
- K042192LOW FLOW OSV II HYDROCEPHALUS VALVE2Cleared 510(K)
- K040943MEDTRONIC PS MEDICAL STRATA VALVE2Cleared 510(K)
- K041296MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI2Cleared 510(K)
- K033704MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS2Cleared 510(K)
- K033017PHOENIX INFUSION CATHETER2Cleared 510(K)
- K040201MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM2Cleared 510(K)
- K031097POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB2Cleared 510(K)
- K033850MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE2Cleared 510(K)
- K033698CONTOUR-FLEX VALVE AND SHUNT SYSTEM2Cleared 510(K)
- K030468ACURA ELITE GRAVITY COMPENSATING RESERVOIR2Cleared 510(K)
- K032817EXTERNAL DRAINAGE SET2Cleared 510(K)
- K030081CSF400 AND CSF6002Cleared 510(K)
- K031303AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)2Cleared 510(K)
- K030698AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV2Cleared 510(K)
- K030289HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N2Cleared 510(K)
- K024101PHOENIX UNIVERSAL SHUNT SYSTEM2Cleared 510(K)
- K024040ACCURA ELITE SHUNT SYSTEM2Cleared 510(K)
- K022554MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM2Cleared 510(K)
- K021644PERF (OMMAYA STYLE) RESERVOIRS2Cleared 510(K)
- K021653CODMAN BACTISEAL EVD CATHETER SET2Cleared 510(K)
- K021196NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN10007352Cleared 510(K)
- K020667CODMAN HAKIM SHUNT SYSTEMS2Cleared 510(K)
- K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM82Cleared 510(K)
- K011030AESCULAP -MIETHKE SHUNT SYSTEM2Cleared 510(K)
- K012052MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 928552Cleared 510(K)
- K003564HAKIM PROGRAMMER AND TRANSMITTER2Cleared 510(K)
- K002970SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-99012Cleared 510(K)
- K002476LUMBOPERITONEAL SHUNT SYSTEM2Cleared 510(K)
- K992465SOPHY SU8 PRESSURE ADJUSTABLE VALVE2Cleared 510(K)
- K991502MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 200222Cleared 510(K)
- K992226XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM2Cleared 510(K)
- K000514RUMBAR DRAINAGE SYSTEM2Cleared 510(K)
- K992173SIPHONGUARD CSF CONTROL DEVICE2Cleared 510(K)
- K000057RADIONICS LUMBOPERITONEAL SHUNT2Cleared 510(K)
- K990660NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX2Cleared 510(K)
- K992379RADIONICS XDC EXTERNAL VENTRICULAR CATHETER2Cleared 510(K)
- K981246BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)2Cleared 510(K)
- K991429DIAMOND II VALVE2Cleared 510(K)
- K980903RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT2Cleared 510(K)
- K990256CRX WORLD SHUNT2Cleared 510(K)
- K984583THE BIOPLATE SHUNT CONNECTOR2Cleared 510(K)
- K984053BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM2Cleared 510(K)
- K974096CRX DIAMOND VALVE2Cleared 510(K)
- K980778HAKIM MICRO PROGRAMMABLE VALVE SYSTEM2Cleared 510(K)
- K974739HAKIM PROGRAMMABLE VALVE SYSTEM2Cleared 510(K)
- K981046MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 961182Cleared 510(K)
- K974726SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER2Cleared 510(K)
- K974708GEMINI STANDARD AND MINI VALVES2Cleared 510(K)
- K971799PRECISION FLOW OSV II2Cleared 510(K)
- K973774CODMAN HAKIM MICRO PRECISION VALVE2Cleared 510(K)
- K973525MAURICE WORLDWIDE SHUNT SYSTEM2Cleared 510(K)
- K972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS2Cleared 510(K)
- K971617ENDOSCOPIC VENTRICULAR CATHETER2Cleared 510(K)
- K971511RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE2Cleared 510(K)
- K964923CODMAN LUMBAR DRAINAGE CATHETER KIT2Cleared 510(K)
- K970983PERITONEAL/CARDIAC CATHETER2Cleared 510(K)
- K970578RADIONICS BURR HOLE VALVE2Cleared 510(K)
- K970658LUMBAR DRAINAGE ACCESSORY KIT2Cleared 510(K)
- K964386RADIONICS CONTOUR FLEX PLUS VALVE2Cleared 510(K)
- K964371SHUNT TAP WITH ICP MONITORING ACCESS PORT2Cleared 510(K)
- K955265CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER2Cleared 510(K)
- K961859NOVUS STANDARD AND PEDIATRIC VALVES2Cleared 510(K)
- K963802SHUNT TAP2Cleared 510(K)
- K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)2Cleared 510(K)
- K962990RADIONICS SIPHON LIMITING DEVICE (SLD)2Cleared 510(K)
- K962097VENTRICULAR CATHETER SET2Cleared 510(K)
- K960435PHOENIX CRX VALVE2Cleared 510(K)
- K955832CORDIS VENTRICULAR ANTECHAMBER (VA)2Cleared 510(K)
- K954285CONTOUR FLEX VALVES (REGULAR & SMALL)2Cleared 510(K)
- K954021EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)2Cleared 510(K)
- K944595CORDIS HORIZONTAL-VERICAL VALVE SYSTEM2Cleared 510(K)
- K951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT2Cleared 510(K)
- K944222CODMAN-MEDOS VALVE SHUNT SYSTEM2Cleared 510(K)
- K932769CAMINO VENTRICULAR DRAINAGE SYSTEM2Cleared 510(K)
- K935560PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)2Cleared 510(K)
- K932429CORDIS GRAVITY COMPENSATING ACCESSORY2Cleared 510(K)
- K934545PS MEDICAL DELTA BURR HOLE VALVE2Cleared 510(K)
- K925810CORDIS POLYPROPYLENE BURR HOLE RESERVOIR2Cleared 510(K)
- K931989VENTRI-CATH2Cleared 510(K)
- K930222CAMINO VENTRICULAR ACCESS DEVICE2Cleared 510(K)
- K913412PS MEDICAL CSF-ACCESS DEVICE2Cleared 510(K)
- K924600INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS2Cleared 510(K)
- K921936CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR2Cleared 510(K)
- K922941CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA2Cleared 510(K)
- K922936CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE2Cleared 510(K)
- K920156CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY2Cleared 510(K)
- K914995CORDIS STRAIGHT VENTRICULAR CATHETER2Cleared 510(K)
- K913842CORDIS RIGHT-ANGLE CATHETER GUIDE2Cleared 510(K)
- K913636ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING2Cleared 510(K)
- K911433RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE2Cleared 510(K)
- K905860HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION2Cleared 510(K)
- K910938CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)2Cleared 510(K)
- K904883OPTYX2Cleared 510(K)
- K911410PS MEDICAL BUTTON VALVE2Cleared 510(K)
- K910853GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET2Cleared 510(K)
- K903844OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING2Cleared 510(K)
- K904120ACCU-FLO* UNITIZED SHUNT2Cleared 510(K)
- K902783PS MEDICAL DELTA CSF-FLOW CONTROL VALVE2Cleared 510(K)
- K902257CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)2Cleared 510(K)
- K895524HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.2Cleared 510(K)
- K900676CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT2Cleared 510(K)
- K896167PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR2Cleared 510(K)
- K892215UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT2Cleared 510(K)
- K894072THE PUDENZ IN LINE VALVE2Cleared 510(K)
- K891456HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM2Cleared 510(K)
- K884036PMT MODEL 1110-5 PMT PERITONEAL CATHETER2Cleared 510(K)
- K881616PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-12Cleared 510(K)
- K883114SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-12Cleared 510(K)
- K875287H-H FLUSHING RESERVOIR2Cleared 510(K)
- K875205TRI-FLOW CATHETER2Cleared 510(K)
- K874508H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG2Cleared 510(K)
- K873247CSF-FLOW CONTROL VALVE, ULTRA SMALL2Cleared 510(K)
- K871685HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS2Cleared 510(K)
- K871752CSF-CARDIAC/PERITONEAL CATHETER2Cleared 510(K)
- K870660H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS2Cleared 510(K)
- K864676HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM2Cleared 510(K)
- K862907P-S MEDICAL CSF-SIPHON CONTROL DEVICE2Cleared 510(K)
- K862303BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.2Cleared 510(K)
- K861961CAMINO CSF DRAINAGE SYSTEM MODEL 0402Cleared 510(K)
- K862513EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS2Cleared 510(K)
- K861377STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES2Cleared 510(K)
- K855058EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID2Cleared 510(K)
- K854474EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE2Cleared 510(K)
- K854049HEYER-SCHULTE SYRINGO PERITONEAL SHUNT2Cleared 510(K)
- K853371H-H ATRIAL CATHETERS & PERITONEAL CATHETERS2Cleared 510(K)
- K853215ACCU-FLO PRESSURE VALVE2Cleared 510(K)
- K853366H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT2Cleared 510(K)
- K853369H-H FIXATION & JOINING CONNECTORS2Cleared 510(K)
- K853365H-H FIFTH VENTRICLE2Cleared 510(K)
- K853364H-H RICKHAM TYPE RESERVOIR2Cleared 510(K)
- K853363H-H CRUCIFORM-SLIT VALVE2Cleared 510(K)
- K853362H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER2Cleared 510(K)
- K853361H-H VENTRICULAR CATHETERS & RESERVOIRS2Cleared 510(K)
- K843132RADIONICS MINI & STANDARD SHUNT VALVE2Cleared 510(K)
- K841442P-S MEDICAL CSF-FLOW CONTROL VALVE-2Cleared 510(K)
- K834593ONE-PIECE SHUNT2Cleared 510(K)
- K831396P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT2Cleared 510(K)
- K831678P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR2Cleared 510(K)
- K830894H-H IN-LINE VALVED CATHETER 2 TYPES2Cleared 510(K)
- K823503P-S CSF-VENTRICULAR CATHETER, FLANGED2Cleared 510(K)
- K823509P-S MED. LUMBO PERITONEAL & VENTRICULO-2Cleared 510(K)
- K820312H-H RICKHAM TYPE RESERVOIR2Cleared 510(K)
- K820311H-H BURR HOLE CATHETER SUPPORT2Cleared 510(K)
- K820247EXTERNAL VENTRICULAR DRAINAGE SYS.2Cleared 510(K)
- K811288SPETZLER LUMBAR-PERITONEAL SYSTEM2Cleared 510(K)
- K803257CSG-FLOW CONTROL VALVE2Cleared 510(K)
- K802586AMERICAN HEYER-SCHULTE LOW PROFILE VALVE2Cleared 510(K)
- K800168H-H FIFTH VENTRICLE2Cleared 510(K)
- K792007CSF-VENTRICULAR CATHETER, STANDARD DES2Cleared 510(K)
- K792005CSF-CARDIAC/PERITONEAL CATHETER2Cleared 510(K)
- K791076H-H SLOTTED VENTRICULAR CATHETER2Cleared 510(K)
- K791075H-H SLOTTED CATHETER-RESERVOIR2Cleared 510(K)
- K790849H-H FIXATION AND JOINING CONNECTORS2Cleared 510(K)
- K790126VALVE, H-H CRUCIFORM SLIT2Cleared 510(K)
- K782105CATHETERS, H-H VENTRICULAR2Cleared 510(K)
- K781768CATHETERS, H-H ATRIAL AND PERITONEAL2Cleared 510(K)
- K760785MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH2Cleared 510(K)
- K760784MISHLER 2 CHAMB FLUSHING VALVE,STAND2Cleared 510(K)
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- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCFNeuromuscular Tongue Stimulator To Treat Motor Deficits2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product Code
- SENBiofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K031097
- 510(k) Type
- Traditional
- Applicant
- Sophysa SA
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/26/2004
- Days to Decision
- 325 days
- Submission Type
- Summary