Shunt, Central Nervous System And Components
Regulation 882.5550
4510(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) |
|---|---|---|---|
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and Terminated |
JXG | K984053 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of simil Terminated |
JXG | K984053 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of simil Terminated |
JXG | K984053 |
| Jun 2, 2014 | Aesculap, Inc. Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System
The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the Terminated |
JXG | K031303 |
| Apr 17, 2014 | Codman & Shurtleff, Inc. CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows:
82-8800 In Line Valve Only
82-8801 In Line Valve with Catheter and Accessories
82-8802 In Line Valve with Unitized Terminated |
JXG | K112156 K113526 |
| Feb 19, 2014 | Aesculap, Inc. Aesculap proSA Adjustment Disc Size Large (L)
The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. Terminated |
JXG | K120559 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories
Product Code: 82-8807
Product Usage:
The CODMAN CERTAS Programmable Valve is an i Terminated |
JXG | K112156 K113526 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories
Product Code: 82-8806
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device Terminated |
JXG | K112156 K113526 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories
Product Code: 82-8805
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device tha Terminated |
JXG | K112156 K113526 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device
Product Code: 82-8804
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant i Terminated |
JXG | K112156 K113526 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories
Product Code: 82-8803
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that Terminated |
JXG | K112156 K113526 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with Catheter and Accessories
Product Code: 82-8801
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant Terminated |
JXG | K112156 K113526 |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve Only
Product Code: 82-8800
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressur Terminated |
JXG | K112156 K113526 |
| Jan 3, 2014 | Integra LifeSciences Corp. Integra Large Rickham -Style Reservoir
Rx Only Sterile for Single Use Only
Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA
NL 850-1132
Provides access to the later Terminated |
JXG | None listed |
| Jan 3, 2014 | Integra LifeSciences Corp. Integra Small Rickham -Style Reservoir
Rx Only Sterile for Single Use Only
Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA
NL 850-1121
Provides access to the later Terminated |
JXG | None listed |
| Dec 20, 2013 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Cranial Access Kit, Model Number HITHSP10, Rx Only.
Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is Terminated |
JXG | K042359 |
| Nov 26, 2013 | Medtronic Neurosurgery Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848.
Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into th Terminated |
JXG | K042465 |
| Nov 26, 2013 | Medtronic Neurosurgery Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201.
Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain Terminated |
JXG | K902783 |
| Nov 26, 2013 | Medtronic Neurosurgery CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022;
CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Terminated |
JXG | K792005 K792007 +1 |
| Feb 12, 2013 | Aesculap, Inc. Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide
Central Nervous System Shunt and Components intended to shu Terminated |
JXG | K020728 K110206 |
| Jul 10, 2012 | Integra LifeSciences Corp Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospina Terminated |
JXG | K760501 |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058"***Plainsboro, NJ***"
Step down connector to be secure with ligature Terminated |
JXG | K811288 K854049 |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ***"
Needle for lumbar peritoneal shunt Terminated |
JXG | K811288 K854049 |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***"
Collars for lumbar peritoneal shunt Terminated |
JXG | K811288 K854049 |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***"
Needle for lumbar peritoneal shunt Terminated |
JXG | K811288 K854049 |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***"
Stainless steel stylet for ventr Terminated |
JXG | K811288 K854049 |
| Sep 8, 2009 | Integra Neuro Sciences Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL9 Terminated |
JXG | K904883 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed po Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed po Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is the Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek plastic tray placed wit Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | K792007 K874498 +2 |
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