ClearanceBrief
Panels › Neurology › Product code JXG · Class 2

Shunt, Central Nervous System And Components

Regulation 882.5550

5510(k)s in 12 months (260 all time)
1recalls in 12 months (108 all time)
103recalls that name a 510(k)
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Top companies in JXG

DateFirm and productCodeLinked 510(k)
May 13, 2026Integra LifeSciences Corp. (NeuroSciences)
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverti
Open, Classified
JXGK170599
Jan 17, 2025Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydro
Open, Classified
JXGNone listed
Jan 17, 2025Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hy
Open, Classified
JXGK223330
Jan 17, 2025Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydro
Open, Classified
JXGNone listed
Jun 12, 2024Integra LifeSciences Corp.
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospina
Open, Classified
JXGK233448
Jun 12, 2024Integra LifeSciences Corp.
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) a
Open, Classified
JXGK233448
Jun 12, 2024Integra LifeSciences Corp.
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other
Open, Classified
JXGK233448
Jan 4, 2024Natus Medical Incorporated
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Open, Classified
JXGK162437
Jan 4, 2024Natus Medical Incorporated
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Open, Classified
JXGK162437
Aug 17, 2023Medtronic Neurosurgery
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Open, Classified
JXGK984053
Jan 12, 2021Natus Manufacturing Limited
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of
Terminated
JXGK162437
Jan 11, 2021Medtronic Neurosurgery
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M -
Open, Classified
JXGK792007
K831678 +3
Jan 11, 2021Medtronic Neurosurgery
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNA
Open, Classified
JXGK033850
K042465 +3
Jan 11, 2021Medtronic Neurosurgery
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML P
Open, Classified
JXGK042465
K862907 +2
Dec 16, 2020Medtronic Neurosurgery
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des
Open, Classified
JXGK902783
Dec 16, 2020Medtronic Neurosurgery
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des
Open, Classified
JXGK902783
Dec 16, 2020Medtronic Neurosurgery
REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des
Open, Classified
JXGK902783
Dec 14, 2020Integra LifeSciences Corp.
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number
Terminated
JXGK110751
Dec 14, 2020Integra LifeSciences Corp.
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF)
Terminated
JXGK172022
Dec 8, 2020Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid
Open, Classified
JXGK110560
Dec 8, 2020Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid
Open, Classified
JXGK110560
Dec 8, 2020Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid
Open, Classified
JXGK110560
May 20, 2019Integra LifeSciences Corp.
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 I
Terminated
JXGK072929
May 20, 2019Integra LifeSciences Corp.
MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the
Terminated
JXGK022554
K062599
May 20, 2019Integra LifeSciences Corp.
MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole
Terminated
JXGK022554
K062599 +1
Sep 21, 2017Aesculap Implant Systems LLC
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Terminated
JXGK161853
Apr 7, 2017Medtronic Neurosurgery
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the periton
Terminated
JXGK152700
Feb 2, 2017Medtronic Neurosurgery
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve
Terminated
JXGK033850
K042465 +2
Aug 23, 2016Integra LifeSciences Corp.
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary pa
Terminated
JXGK032817
Aug 23, 2016Integra LifeSciences Corp.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches ar
Terminated
JXGK914995
Aug 23, 2016Integra LifeSciences Corp.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Terminated
JXGK855058
Aug 23, 2016Integra LifeSciences Corp.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary pack
Terminated
JXGK924600
Aug 23, 2016Integra LifeSciences Corp.
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard bo
Terminated
JXGNone listed
Aug 23, 2016Integra LifeSciences Corp.
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Cat
Terminated
JXGK033698
Jan 26, 2015Aesculap, Inc.
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Terminated
JXGK120559
Dec 16, 2014Aesculap, Inc.
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Terminated
JXGK110206
Dec 3, 2014Aesculap, Inc.
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Terminated
JXGK011030
Oct 20, 2014Codman & Shurtleff, Inc.
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characterist
Terminated
JXGK061568
Oct 20, 2014Codman & Shurtleff, Inc.
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characte
Terminated
JXGK061568
Oct 20, 2014Codman & Shurtleff, Inc.
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characte
Terminated
JXGK061568
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides c
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intravent
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventri
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and d
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventri
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pres
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and
Terminated
JXGK112156
K113526
Aug 12, 2014Codman & Shurtleff, Inc.
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebros
Terminated
JXGK112156
K113526
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and othe
Terminated
JXGK984053
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and
Terminated
JXGK984053

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