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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
K
24
1458
Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
2
Cleared 510(K)
K
23
3445
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
2
Cleared 510(K)
K
23
3448
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
2
Cleared 510(K)
K
23
1664
IRRAflow Active Fluid Exchange System (AFES)
2
Cleared 510(K)
K
22
1694
External Drainage System
2
Cleared 510(K)
K
22
2422
Polaris Valve Electronic Reading Instrument
2
Cleared 510(K)
K
22
3330
Certas Plus Programmable Valves
2
Cleared 510(K)
K
22
3603
Reflow System Mini and ReFlow Mini Flusher
2
Cleared 510(K)
K
22
2471
IRRAflow Active Fluid Exchange System (AFES)
2
Cleared 510(K)
K
22
1840
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
2
Cleared 510(K)
K
22
1918
ReFlow System Mini
2
Cleared 510(K)
K
21
2641
StrataMR II Valves and Shunts
2
Cleared 510(K)
K
20
0950
Ventricular Catheter
2
Cleared 510(K)
K
20
0807
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
2
Cleared 510(K)
K
19
2266
M. Blue Adjustable Shunt System
2
Cleared 510(K)
K
19
2289
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
2
Cleared 510(K)
K
19
1684
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
2
Cleared 510(K)
K
19
0174
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
2
Cleared 510(K)
K
18
2265
CodMan Certas Plus Programmable Valve
2
Cleared 510(K)
K
18
1902
Codman Certas Plus Electronic Tool Kit
2
Cleared 510(K)
K
18
1622
StrataMR guider tool
2
Cleared 510(K)
K
17
1880
IRRAflow CNS System
2
Cleared 510(K)
K
18
1301
Smart External Drain (SED) System
2
Cleared 510(K)
K
17
2035
EKOS ultrasound EVD Device, EVD Control Unit
2
Cleared 510(K)
K
17
2759
Smart External Drain (SED) System
2
Cleared 510(K)
K
17
2006
Alivio Ventricular Catheter and Flusher System (Alivio System)
2
Cleared 510(K)
K
17
2537
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
2
Cleared 510(K)
K
17
2022
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
2
Cleared 510(K)
K
17
0599
SureFlo EVD Catheter
2
Cleared 510(K)
K
17
1586
Smart External Drain (SED) System
2
Cleared 510(K)
K
16
1853
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
2
Cleared 510(K)
K
16
2437
Codman EDS3 CSF External Drainage System
2
Cleared 510(K)
K
16
1605
Smart External Drain (SED) System
2
Cleared 510(K)
K
16
1992
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
2
Cleared 510(K)
K
15
2700
StrataMR Valves and Shunts
2
Cleared 510(K)
K
15
3041
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
2
Cleared 510(K)
K
15
2897
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
2
Cleared 510(K)
K
15
0898
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
2
Cleared 510(K)
K
15
2152
Codman Certas Plus Programmable Valve
2
Cleared 510(K)
K
14
1687
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
2
Cleared 510(K)
K
14
1227
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
2
Cleared 510(K)
K
14
3111
Codman Certas Plus Programmable Valve; Codman Certas Toll Kit
2
Cleared 510(K)
K
14
0722
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
2
Cleared 510(K)
K
12
1248
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
2
Cleared 510(K)
K
12
3554
SHUNTCHECK
2
Cleared 510(K)
K
12
3524
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
2
Cleared 510(K)
K
12
2118
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
2
Cleared 510(K)
K
12
0559
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
2
Cleared 510(K)
K
11
3526
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
2
Cleared 510(K)
K
11
0560
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
2
Cleared 510(K)
K
11
0206
AESCULAP- MEITHKE SHUNT SYSTEM
2
Cleared 510(K)
K
11
2156
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
2
Cleared 510(K)
K
10
1381
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
2
Cleared 510(K)
K
11
0751
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
2
Cleared 510(K)
K
10
2961
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
2
Cleared 510(K)
K
10
2589
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
2
Cleared 510(K)
K
10
3003
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
2
Cleared 510(K)
K
09
3968
OSV II LOW FLOW LOW PRO VALVE
2
Cleared 510(K)
K
09
1328
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
2
Cleared 510(K)
K
09
2395
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
2
Cleared 510(K)
K
09
1312
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
2
Cleared 510(K)
K
09
0342
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
2
Cleared 510(K)
K
09
1346
CODMAN HAKIM MICRO II VALVE
2
Cleared 510(K)
K
09
0348
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
2
Cleared 510(K)
K
08
3076
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
2
Cleared 510(K)
K
08
1773
OSV II
2
Cleared 510(K)
K
08
2127
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
2
Cleared 510(K)
K
08
1942
NEUROCATH AG
2
Cleared 510(K)
K
08
0168
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
2
Cleared 510(K)
K
07
3139
SMALL LUMEN PERITONEAL CATHETER
2
Cleared 510(K)
K
07
2929
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
2
Cleared 510(K)
K
06
3836
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
2
Cleared 510(K)
K
06
2009
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
2
Cleared 510(K)
K
06
1876
CODMAN VPV SYSTEM, MODEL 82-3192
2
Cleared 510(K)
K
06
1568
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
2
Cleared 510(K)
K
06
2599
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
2
Cleared 510(K)
K
06
0681
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
2
Cleared 510(K)
K
05
3350
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
2
Cleared 510(K)
K
05
3107
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
2
Cleared 510(K)
K
05
2386
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
2
Cleared 510(K)
K
05
0739
CODMAN VPV SYSTEM, MODEL 82-3192
2
Cleared 510(K)
K
04
1992
MEDTRONIC STRATAVARIUS
2
Cleared 510(K)
K
04
2825
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
2
Cleared 510(K)
K
04
2481
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
2
Cleared 510(K)
K
04
2359
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
2
Cleared 510(K)
K
04
0021
SHUNTCHECK (PROMETHEUS 1)
2
Cleared 510(K)
K
04
2465
PS MEDICAL STRATA II VALVE
2
Cleared 510(K)
K
04
2558
EQUI-FLOW VALVE AND SHUNT SYSTEM
2
Cleared 510(K)
K
04
2198
PS MEDICAL NEUROSURGICAL IMPLANTS
2
Cleared 510(K)
K
04
2192
LOW FLOW OSV II HYDROCEPHALUS VALVE
2
Cleared 510(K)
K
04
0943
MEDTRONIC PS MEDICAL STRATA VALVE
2
Cleared 510(K)
K
04
1296
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
2
Cleared 510(K)
K
03
3704
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
2
Cleared 510(K)
K
03
3017
PHOENIX INFUSION CATHETER
2
Cleared 510(K)
K
04
0201
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
2
Cleared 510(K)
K
03
1097
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
2
Cleared 510(K)
K
03
3850
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
2
Cleared 510(K)
K
03
3698
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
2
Cleared 510(K)
K
03
0468
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
2
Cleared 510(K)
K
03
2817
EXTERNAL DRAINAGE SET
2
Cleared 510(K)
K
03
0081
CSF400 AND CSF600
2
Cleared 510(K)
K
03
1303
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
2
Cleared 510(K)
K
03
0698
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
2
Cleared 510(K)
K
03
0289
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
2
Cleared 510(K)
K
02
4101
PHOENIX UNIVERSAL SHUNT SYSTEM
2
Cleared 510(K)
K
02
4040
ACCURA ELITE SHUNT SYSTEM
2
Cleared 510(K)
K
02
2554
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
2
Cleared 510(K)
K
02
1644
PERF (OMMAYA STYLE) RESERVOIRS
2
Cleared 510(K)
K
02
1653
CODMAN BACTISEAL EVD CATHETER SET
2
Cleared 510(K)
K
02
1196
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
2
Cleared 510(K)
K
02
0667
CODMAN HAKIM SHUNT SYSTEMS
2
Cleared 510(K)
K
01
3488
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
2
Cleared 510(K)
K
01
1030
AESCULAP -MIETHKE SHUNT SYSTEM
2
Cleared 510(K)
K
01
2052
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
2
Cleared 510(K)
K
00
3564
HAKIM PROGRAMMER AND TRANSMITTER
2
Cleared 510(K)
K
00
2970
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
2
Cleared 510(K)
K
00
2476
LUMBOPERITONEAL SHUNT SYSTEM
2
Cleared 510(K)
K
99
2465
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
2
Cleared 510(K)
K
99
1502
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
2
Cleared 510(K)
K
99
2226
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
2
Cleared 510(K)
K
00
0514
RUMBAR DRAINAGE SYSTEM
2
Cleared 510(K)
K
99
2173
SIPHONGUARD CSF CONTROL DEVICE
2
Cleared 510(K)
K
00
0057
RADIONICS LUMBOPERITONEAL SHUNT
2
Cleared 510(K)
K
99
0660
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
2
Cleared 510(K)
K
99
2379
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
2
Cleared 510(K)
K
98
1246
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
2
Cleared 510(K)
K
99
1429
DIAMOND II VALVE
2
Cleared 510(K)
K
98
0903
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
2
Cleared 510(K)
K
99
0256
CRX WORLD SHUNT
2
Cleared 510(K)
K
98
4583
THE BIOPLATE SHUNT CONNECTOR
2
Cleared 510(K)
K
98
4053
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
2
Cleared 510(K)
K
97
4096
CRX DIAMOND VALVE
2
Cleared 510(K)
K
98
0778
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
2
Cleared 510(K)
K
97
4739
HAKIM PROGRAMMABLE VALVE SYSTEM
2
Cleared 510(K)
K
98
1046
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
2
Cleared 510(K)
K
97
4726
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
2
Cleared 510(K)
K
97
4708
GEMINI STANDARD AND MINI VALVES
2
Cleared 510(K)
K
97
1799
PRECISION FLOW OSV II
2
Cleared 510(K)
K
97
3774
CODMAN HAKIM MICRO PRECISION VALVE
2
Cleared 510(K)
K
97
3525
MAURICE WORLDWIDE SHUNT SYSTEM
2
Cleared 510(K)
K
97
2994
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
2
Cleared 510(K)
K
97
1617
ENDOSCOPIC VENTRICULAR CATHETER
2
Cleared 510(K)
K
97
1511
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
2
Cleared 510(K)
K
96
4923
CODMAN LUMBAR DRAINAGE CATHETER KIT
2
Cleared 510(K)
K
97
0983
PERITONEAL/CARDIAC CATHETER
2
Cleared 510(K)
K
97
0578
RADIONICS BURR HOLE VALVE
2
Cleared 510(K)
K
97
0658
LUMBAR DRAINAGE ACCESSORY KIT
2
Cleared 510(K)
K
96
4386
RADIONICS CONTOUR FLEX PLUS VALVE
2
Cleared 510(K)
K
96
4371
SHUNT TAP WITH ICP MONITORING ACCESS PORT
2
Cleared 510(K)
K
95
5265
CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER
2
Cleared 510(K)
K
96
1859
NOVUS STANDARD AND PEDIATRIC VALVES
2
Cleared 510(K)
K
96
3802
SHUNT TAP
2
Cleared 510(K)
K
96
0159
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
2
Cleared 510(K)
K
96
2990
RADIONICS SIPHON LIMITING DEVICE (SLD)
2
Cleared 510(K)
K
96
2097
VENTRICULAR CATHETER SET
2
Cleared 510(K)
K
96
0435
PHOENIX CRX VALVE
2
Cleared 510(K)
K
95
5832
CORDIS VENTRICULAR ANTECHAMBER (VA)
2
Cleared 510(K)
K
95
4285
CONTOUR FLEX VALVES (REGULAR & SMALL)
2
Cleared 510(K)
K
95
4021
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
2
Cleared 510(K)
K
94
4595
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
2
Cleared 510(K)
K
95
1258
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
2
Cleared 510(K)
K
94
4222
CODMAN-MEDOS VALVE SHUNT SYSTEM
2
Cleared 510(K)
K
93
2769
CAMINO VENTRICULAR DRAINAGE SYSTEM
2
Cleared 510(K)
K
93
5560
PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
2
Cleared 510(K)
K
93
2429
CORDIS GRAVITY COMPENSATING ACCESSORY
2
Cleared 510(K)
K
93
4545
PS MEDICAL DELTA BURR HOLE VALVE
2
Cleared 510(K)
K
92
5810
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
2
Cleared 510(K)
K
93
1989
VENTRI-CATH
2
Cleared 510(K)
K
93
0222
CAMINO VENTRICULAR ACCESS DEVICE
2
Cleared 510(K)
K
91
3412
PS MEDICAL CSF-ACCESS DEVICE
2
Cleared 510(K)
K
92
4600
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
2
Cleared 510(K)
K
92
1936
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
2
Cleared 510(K)
K
92
2941
CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA
2
Cleared 510(K)
K
92
2936
CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE
2
Cleared 510(K)
K
92
0156
CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY
2
Cleared 510(K)
K
91
4995
CORDIS STRAIGHT VENTRICULAR CATHETER
2
Cleared 510(K)
K
91
3842
CORDIS RIGHT-ANGLE CATHETER GUIDE
2
Cleared 510(K)
K
91
3636
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
2
Cleared 510(K)
K
91
1433
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
2
Cleared 510(K)
K
90
5860
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
2
Cleared 510(K)
K
91
0938
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
2
Cleared 510(K)
K
90
4883
OPTYX
2
Cleared 510(K)
K
91
1410
PS MEDICAL BUTTON VALVE
2
Cleared 510(K)
K
91
0853
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
2
Cleared 510(K)
K
90
3844
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
2
Cleared 510(K)
K
90
4120
ACCU-FLO* UNITIZED SHUNT
2
Cleared 510(K)
K
90
2783
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
2
Cleared 510(K)
K
90
2257
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
2
Cleared 510(K)
K
89
5524
HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
2
Cleared 510(K)
K
90
0676
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
2
Cleared 510(K)
K
89
6167
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
2
Cleared 510(K)
K
89
2215
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
2
Cleared 510(K)
K
89
4072
THE PUDENZ IN LINE VALVE
2
Cleared 510(K)
K
89
1456
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
2
Cleared 510(K)
K
88
4036
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
2
Cleared 510(K)
K
88
1616
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
2
Cleared 510(K)
K
88
3114
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
2
Cleared 510(K)
K
87
5287
H-H FLUSHING RESERVOIR
2
Cleared 510(K)
K
87
5205
TRI-FLOW CATHETER
2
Cleared 510(K)
K
87
4508
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
2
Cleared 510(K)
K
87
3247
CSF-FLOW CONTROL VALVE, ULTRA SMALL
2
Cleared 510(K)
K
87
1685
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
2
Cleared 510(K)
K
87
1752
CSF-CARDIAC/PERITONEAL CATHETER
2
Cleared 510(K)
K
87
0660
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
2
Cleared 510(K)
K
86
4676
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
2
Cleared 510(K)
K
86
2907
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
2
Cleared 510(K)
K
86
2303
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
2
Cleared 510(K)
K
86
1961
CAMINO CSF DRAINAGE SYSTEM MODEL 040
2
Cleared 510(K)
K
86
2513
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
2
Cleared 510(K)
K
86
1377
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
2
Cleared 510(K)
K
85
5058
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
2
Cleared 510(K)
K
85
4474
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
2
Cleared 510(K)
K
85
4049
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
2
Cleared 510(K)
K
85
3371
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
2
Cleared 510(K)
K
85
3215
ACCU-FLO PRESSURE VALVE
2
Cleared 510(K)
K
85
3369
H-H FIXATION & JOINING CONNECTORS
2
Cleared 510(K)
K
85
3366
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT
2
Cleared 510(K)
K
85
3365
H-H FIFTH VENTRICLE
2
Cleared 510(K)
K
85
3364
H-H RICKHAM TYPE RESERVOIR
2
Cleared 510(K)
K
85
3363
H-H CRUCIFORM-SLIT VALVE
2
Cleared 510(K)
K
85
3362
H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
2
Cleared 510(K)
K
85
3361
H-H VENTRICULAR CATHETERS & RESERVOIRS
2
Cleared 510(K)
K
84
3132
RADIONICS MINI & STANDARD SHUNT VALVE
2
Cleared 510(K)
K
84
1442
P-S MEDICAL CSF-FLOW CONTROL VALVE-
2
Cleared 510(K)
K
83
4593
ONE-PIECE SHUNT
2
Cleared 510(K)
K
83
1396
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT
2
Cleared 510(K)
K
83
1678
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
2
Cleared 510(K)
K
83
0894
H-H IN-LINE VALVED CATHETER 2 TYPES
2
Cleared 510(K)
K
82
3503
P-S CSF-VENTRICULAR CATHETER, FLANGED
2
Cleared 510(K)
K
82
3509
P-S MED. LUMBO PERITONEAL & VENTRICULO-
2
Cleared 510(K)
K
82
0312
H-H RICKHAM TYPE RESERVOIR
2
Cleared 510(K)
K
82
0311
H-H BURR HOLE CATHETER SUPPORT
2
Cleared 510(K)
K
82
0247
EXTERNAL VENTRICULAR DRAINAGE SYS.
2
Cleared 510(K)
K
81
1288
SPETZLER LUMBAR-PERITONEAL SYSTEM
2
Cleared 510(K)
K
80
3257
CSG-FLOW CONTROL VALVE
2
Cleared 510(K)
K
80
2586
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
2
Cleared 510(K)
K
80
0168
H-H FIFTH VENTRICLE
2
Cleared 510(K)
K
79
2005
CSF-CARDIAC/PERITONEAL CATHETER
2
Cleared 510(K)
K
79
2007
CSF-VENTRICULAR CATHETER, STANDARD DES
2
Cleared 510(K)
K
79
1076
H-H SLOTTED VENTRICULAR CATHETER
2
Cleared 510(K)
K
79
1075
H-H SLOTTED CATHETER-RESERVOIR
2
Cleared 510(K)
K
79
0849
H-H FIXATION AND JOINING CONNECTORS
2
Cleared 510(K)
K
79
0126
VALVE, H-H CRUCIFORM SLIT
2
Cleared 510(K)
K
78
2105
CATHETERS, H-H VENTRICULAR
2
Cleared 510(K)
K
78
1768
CATHETERS, H-H ATRIAL AND PERITONEAL
2
Cleared 510(K)
K
76
0784
MISHLER 2 CHAMB FLUSHING VALVE,STAND
2
Cleared 510(K)
K
76
0785
MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH
2
Cleared 510(K)
K
76
0502
VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.
2
Cleared 510(K)
K
76
0501
VALVE, STANDARD MODEL PUDENZE FLUSHING
2
Cleared 510(K)
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
NE
/
subpart-f—neurological-therapeutic-devices
/
JXG
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K080168
View Source
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080168
510(k) Type
Traditional
Applicant
NEURO DIAGNOSTIC DEVICES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2008
Days to Decision
114 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
K
24
1458
Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
K
23
3445
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
K
23
3448
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
K
23
1664
IRRAflow Active Fluid Exchange System (AFES)
K
22
1694
External Drainage System
K
22
2422
Polaris Valve Electronic Reading Instrument
K
22
3330
Certas Plus Programmable Valves
K
22
3603
Reflow System Mini and ReFlow Mini Flusher
K
22
2471
IRRAflow Active Fluid Exchange System (AFES)
K
22
1840
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K
22
1918
ReFlow System Mini
K
21
2641
StrataMR II Valves and Shunts
K
20
0950
Ventricular Catheter
K
20
0807
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K
19
2266
M. Blue Adjustable Shunt System
K
19
2289
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K
19
1684
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K
19
0174
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K
18
2265
CodMan Certas Plus Programmable Valve
K
18
1902
Codman Certas Plus Electronic Tool Kit
K
18
1622
StrataMR guider tool
K
17
1880
IRRAflow CNS System
K
18
1301
Smart External Drain (SED) System
K
17
2035
EKOS ultrasound EVD Device, EVD Control Unit
K
17
2759
Smart External Drain (SED) System
K
17
2006
Alivio Ventricular Catheter and Flusher System (Alivio System)
K
17
2537
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K
17
2022
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K
17
0599
SureFlo EVD Catheter
K
17
1586
Smart External Drain (SED) System
K
16
1853
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
K
16
2437
Codman EDS3 CSF External Drainage System
K
16
1605
Smart External Drain (SED) System
K
16
1992
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
K
15
2700
StrataMR Valves and Shunts
K
15
3041
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
K
15
2897
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K
15
0898
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
K
15
2152
Codman Certas Plus Programmable Valve
K
14
1687
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K
14
1227
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K
14
3111
Codman Certas Plus Programmable Valve; Codman Certas Toll Kit
K
14
0722
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K
12
1248
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
K
12
3554
SHUNTCHECK
K
12
3524
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K
12
2118
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K
12
0559
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K
11
3526
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K
11
0560
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K
11
0206
AESCULAP- MEITHKE SHUNT SYSTEM
K
11
2156
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K
10
1381
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K
11
0751
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K
10
2961
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
K
10
2589
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
K
10
3003
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K
09
3968
OSV II LOW FLOW LOW PRO VALVE
K
09
1328
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
K
09
2395
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K
09
1312
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K
09
0342
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
K
09
1346
CODMAN HAKIM MICRO II VALVE
K
09
0348
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
K
08
3076
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
K
08
1773
OSV II
K
08
2127
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
K
08
1942
NEUROCATH AG
K
08
0168
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
K
07
3139
SMALL LUMEN PERITONEAL CATHETER
K
07
2929
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
K
06
3836
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
K
06
2009
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K
06
1876
CODMAN VPV SYSTEM, MODEL 82-3192
K
06
1568
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
K
06
2599
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
K
06
0681
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
K
05
3350
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
K
05
3107
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
K
05
2386
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
K
05
0739
CODMAN VPV SYSTEM, MODEL 82-3192
K
04
1992
MEDTRONIC STRATAVARIUS
K
04
2825
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K
04
2481
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
K
04
2359
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
K
04
0021
SHUNTCHECK (PROMETHEUS 1)
K
04
2465
PS MEDICAL STRATA II VALVE
K
04
2558
EQUI-FLOW VALVE AND SHUNT SYSTEM
K
04
2198
PS MEDICAL NEUROSURGICAL IMPLANTS
K
04
2192
LOW FLOW OSV II HYDROCEPHALUS VALVE
K
04
0943
MEDTRONIC PS MEDICAL STRATA VALVE
K
04
1296
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K
03
3704
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
K
03
3017
PHOENIX INFUSION CATHETER
K
04
0201
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
K
03
1097
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
K
03
3850
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K
03
3698
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
K
03
0468
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
K
03
2817
EXTERNAL DRAINAGE SET
K
03
0081
CSF400 AND CSF600
K
03
1303
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K
03
0698
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K
03
0289
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K
02
4101
PHOENIX UNIVERSAL SHUNT SYSTEM
K
02
4040
ACCURA ELITE SHUNT SYSTEM
K
02
2554
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K
02
1644
PERF (OMMAYA STYLE) RESERVOIRS
K
02
1653
CODMAN BACTISEAL EVD CATHETER SET
K
02
1196
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
K
02
0667
CODMAN HAKIM SHUNT SYSTEMS
K
01
3488
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
K
01
1030
AESCULAP -MIETHKE SHUNT SYSTEM
K
01
2052
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
K
00
3564
HAKIM PROGRAMMER AND TRANSMITTER
K
00
2970
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
K
00
2476
LUMBOPERITONEAL SHUNT SYSTEM
K
99
2465
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K
99
1502
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K
99
2226
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K
00
0514
RUMBAR DRAINAGE SYSTEM
K
99
2173
SIPHONGUARD CSF CONTROL DEVICE
K
00
0057
RADIONICS LUMBOPERITONEAL SHUNT
K
99
0660
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
K
99
2379
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K
98
1246
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
K
99
1429
DIAMOND II VALVE
K
98
0903
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K
99
0256
CRX WORLD SHUNT
K
98
4583
THE BIOPLATE SHUNT CONNECTOR
K
98
4053
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K
97
4096
CRX DIAMOND VALVE
K
98
0778
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K
97
4739
HAKIM PROGRAMMABLE VALVE SYSTEM
K
98
1046
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
K
97
4726
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
K
97
4708
GEMINI STANDARD AND MINI VALVES
K
97
1799
PRECISION FLOW OSV II
K
97
3774
CODMAN HAKIM MICRO PRECISION VALVE
K
97
3525
MAURICE WORLDWIDE SHUNT SYSTEM
K
97
2994
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
K
97
1617
ENDOSCOPIC VENTRICULAR CATHETER
K
97
1511
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K
96
4923
CODMAN LUMBAR DRAINAGE CATHETER KIT
K
97
0983
PERITONEAL/CARDIAC CATHETER
K
97
0578
RADIONICS BURR HOLE VALVE
K
97
0658
LUMBAR DRAINAGE ACCESSORY KIT
K
96
4386
RADIONICS CONTOUR FLEX PLUS VALVE
K
96
4371
SHUNT TAP WITH ICP MONITORING ACCESS PORT
K
95
5265
CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER
K
96
1859
NOVUS STANDARD AND PEDIATRIC VALVES
K
96
3802
SHUNT TAP
K
96
0159
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K
96
2990
RADIONICS SIPHON LIMITING DEVICE (SLD)
K
96
2097
VENTRICULAR CATHETER SET
K
96
0435
PHOENIX CRX VALVE
K
95
5832
CORDIS VENTRICULAR ANTECHAMBER (VA)
K
95
4285
CONTOUR FLEX VALVES (REGULAR & SMALL)
K
95
4021
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K
94
4595
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K
95
1258
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K
94
4222
CODMAN-MEDOS VALVE SHUNT SYSTEM
K
93
2769
CAMINO VENTRICULAR DRAINAGE SYSTEM
K
93
5560
PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
K
93
2429
CORDIS GRAVITY COMPENSATING ACCESSORY
K
93
4545
PS MEDICAL DELTA BURR HOLE VALVE
K
92
5810
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K
93
1989
VENTRI-CATH
K
93
0222
CAMINO VENTRICULAR ACCESS DEVICE
K
91
3412
PS MEDICAL CSF-ACCESS DEVICE
K
92
4600
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K
92
1936
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
K
92
2941
CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA
K
92
2936
CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE
K
92
0156
CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY
K
91
4995
CORDIS STRAIGHT VENTRICULAR CATHETER
K
91
3842
CORDIS RIGHT-ANGLE CATHETER GUIDE
K
91
3636
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K
91
1433
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K
90
5860
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K
91
0938
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K
90
4883
OPTYX
K
91
1410
PS MEDICAL BUTTON VALVE
K
91
0853
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K
90
3844
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K
90
4120
ACCU-FLO* UNITIZED SHUNT
K
90
2783
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
K
90
2257
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K
89
5524
HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
K
90
0676
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
K
89
6167
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K
89
2215
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K
89
4072
THE PUDENZ IN LINE VALVE
K
89
1456
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K
88
4036
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
K
88
1616
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K
88
3114
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K
87
5287
H-H FLUSHING RESERVOIR
K
87
5205
TRI-FLOW CATHETER
K
87
4508
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K
87
3247
CSF-FLOW CONTROL VALVE, ULTRA SMALL
K
87
1685
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
K
87
1752
CSF-CARDIAC/PERITONEAL CATHETER
K
87
0660
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
K
86
4676
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
K
86
2907
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K
86
2303
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
K
86
1961
CAMINO CSF DRAINAGE SYSTEM MODEL 040
K
86
2513
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K
86
1377
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K
85
5058
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K
85
4474
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K
85
4049
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
K
85
3371
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
K
85
3215
ACCU-FLO PRESSURE VALVE
K
85
3369
H-H FIXATION & JOINING CONNECTORS
K
85
3366
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT
K
85
3365
H-H FIFTH VENTRICLE
K
85
3364
H-H RICKHAM TYPE RESERVOIR
K
85
3363
H-H CRUCIFORM-SLIT VALVE
K
85
3362
H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
K
85
3361
H-H VENTRICULAR CATHETERS & RESERVOIRS
K
84
3132
RADIONICS MINI & STANDARD SHUNT VALVE
K
84
1442
P-S MEDICAL CSF-FLOW CONTROL VALVE-
K
83
4593
ONE-PIECE SHUNT
K
83
1396
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT
K
83
1678
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
K
83
0894
H-H IN-LINE VALVED CATHETER 2 TYPES
K
82
3503
P-S CSF-VENTRICULAR CATHETER, FLANGED
K
82
3509
P-S MED. LUMBO PERITONEAL & VENTRICULO-
K
82
0312
H-H RICKHAM TYPE RESERVOIR
K
82
0311
H-H BURR HOLE CATHETER SUPPORT
K
82
0247
EXTERNAL VENTRICULAR DRAINAGE SYS.
K
81
1288
SPETZLER LUMBAR-PERITONEAL SYSTEM
K
80
3257
CSG-FLOW CONTROL VALVE
K
80
2586
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
K
80
0168
H-H FIFTH VENTRICLE
K
79
2005
CSF-CARDIAC/PERITONEAL CATHETER
K
79
2007
CSF-VENTRICULAR CATHETER, STANDARD DES
K
79
1076
H-H SLOTTED VENTRICULAR CATHETER
K
79
1075
H-H SLOTTED CATHETER-RESERVOIR
K
79
0849
H-H FIXATION AND JOINING CONNECTORS
K
79
0126
VALVE, H-H CRUCIFORM SLIT
K
78
2105
CATHETERS, H-H VENTRICULAR
K
78
1768
CATHETERS, H-H ATRIAL AND PERITONEAL
K
76
0784
MISHLER 2 CHAMB FLUSHING VALVE,STAND
K
76
0785
MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH
K
76
0502
VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.
K
76
0501
VALVE, STANDARD MODEL PUDENZE FLUSHING
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—neurological-therapeutic-devices
/
JXG
/
K080168
View Source
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080168
510(k) Type
Traditional
Applicant
NEURO DIAGNOSTIC DEVICES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2008
Days to Decision
114 days
Submission Type
Summary