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)
Top companies in JXG
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neurosurgery | 18 | 49 |
| Codman & Shurtleff, Inc. | 23 | 19 |
| Integra LifeSciences Corporation | 14 | 21 |
| Holter-Hausner Intl. | 21 | 0 |
| Aesculap, Inc. | 14 | 6 |
| Cordis Corp. | 18 | 0 |
| Pudenz-Schulte Medical Research Corp. | 18 | 0 |
| Phoenix Biomedical | 11 | 1 |
| Radionics, Inc. | 10 | 0 |
| Sophysa | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2026 | Integra 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 |
JXG | K170599 |
| Jan 17, 2025 | Integra 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 |
JXG | None listed |
| Jan 17, 2025 | Integra 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 |
JXG | K223330 |
| Jan 17, 2025 | Integra 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 |
JXG | None listed |
| Jun 12, 2024 | Integra 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 |
JXG | K233448 |
| Jun 12, 2024 | Integra 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 |
JXG | K233448 |
| Jun 12, 2024 | Integra 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 |
JXG | K233448 |
| Jan 4, 2024 | Natus Medical Incorporated EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Open, Classified |
JXG | K162437 |
| Jan 4, 2024 | Natus Medical Incorporated External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Open, Classified |
JXG | K162437 |
| Aug 17, 2023 | Medtronic Neurosurgery Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only Open, Classified |
JXG | K984053 |
| Jan 12, 2021 | Natus 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 |
JXG | K162437 |
| Jan 11, 2021 | Medtronic 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 |
JXG | K792007 K831678 +3 |
| Jan 11, 2021 | Medtronic 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 |
JXG | K033850 K042465 +3 |
| Jan 11, 2021 | Medtronic 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 |
JXG | K042465 K862907 +2 |
| Dec 16, 2020 | Medtronic 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 |
JXG | K902783 |
| Dec 16, 2020 | Medtronic 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 |
JXG | K902783 |
| Dec 16, 2020 | Medtronic 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 |
JXG | K902783 |
| Dec 14, 2020 | Integra 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 |
JXG | K110751 |
| Dec 14, 2020 | Integra 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 |
JXG | K172022 |
| Dec 8, 2020 | Medtronic 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 |
JXG | K110560 |
| Dec 8, 2020 | Medtronic 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 |
JXG | K110560 |
| Dec 8, 2020 | Medtronic 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 |
JXG | K110560 |
| May 20, 2019 | Integra 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 |
JXG | K072929 |
| May 20, 2019 | Integra 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 |
JXG | K022554 K062599 |
| May 20, 2019 | Integra 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 |
JXG | K022554 K062599 +1 |
| Sep 21, 2017 | Aesculap Implant Systems LLC proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System
Shunt, central nervous system and components Terminated |
JXG | K161853 |
| Apr 7, 2017 | Medtronic 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 |
JXG | K152700 |
| Feb 2, 2017 | Medtronic 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 |
JXG | K033850 K042465 +2 |
| Aug 23, 2016 | Integra 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 |
JXG | K032817 |
| Aug 23, 2016 | Integra 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 |
JXG | K914995 |
| Aug 23, 2016 | Integra 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 |
JXG | K855058 |
| Aug 23, 2016 | Integra 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 |
JXG | K924600 |
| Aug 23, 2016 | Integra 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 |
JXG | None listed |
| Aug 23, 2016 | Integra 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 |
JXG | K033698 |
| Jan 26, 2015 | Aesculap, 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 |
JXG | K120559 |
| Dec 16, 2014 | Aesculap, 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 |
JXG | K110206 |
| Dec 3, 2014 | Aesculap, Inc. The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus. Terminated |
JXG | K011030 |
| Oct 20, 2014 | Codman & 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 |
JXG | K061568 |
| Oct 20, 2014 | Codman & 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 |
JXG | K061568 |
| Oct 20, 2014 | Codman & 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 |
JXG | K061568 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Aug 12, 2014 | Codman & 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 |
JXG | K112156 K113526 |
| Jun 27, 2014 | Medtronic 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 |
JXG | K984053 |
| Jun 27, 2014 | Medtronic 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 |
JXG | K984053 |
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