Shunt, Central Nervous System And Components

JXG 2025-12-10

Intellidrop

Applicant Brainspace, Inc.

K number K251598

JXG 2025-11-28

Sophy Mini Monopressure Valve (SM1)

Applicant Sophysa

K number K250636

JXG 2025-11-05

EVAC-MRI

Applicant Phasor Health, LLC

K number K252514

JXG 2025-08-08

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Applicant Integra Lifesciences Production Corporation

K number K243531

JXG 2025-08-06

Codman 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)

Applicant Integra Lifesciences Production Corporation

K number K243552

JXG 2025-06-20

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

Applicant Sophysa

K number K242974

JXG 2025-06-03

EVAC

Applicant Phasor Health, LLC

K number K243205

JXG 2025-03-10

Duet External Drainage and Monitoring System (EDMS)

Applicant Medtronic Neurosurgery

K number K243676

JXG 2024-12-16

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set

Applicant Aesculap, Inc.

K number K242003

JXG 2024-08-20

Borvo EVAC System (Ergo); Borvo EVAC System (Classic)

Applicant Borvo Medical, Inc.

K number K241458

JXG 2024-01-17

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

Applicant Integra Lifesciences Production Corporation

K number K233445

JXG 2023-12-19

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

Applicant Integra Lifesciences Production Corporation

K number K233448

JXG 2023-10-19

IRRAflow Active Fluid Exchange System (AFES)

Applicant Irras USA, Inc.

K number K231664

JXG 2023-02-09

External Drainage System

Applicant Jmed(Shenzhen) Technology Limited

K number K221694

JXG 2023-02-02

Polaris Valve Electronic Reading Instrument

Applicant Sophysa

K number K222422

JXG 2023-02-01

Certas Plus Programmable Valves

Applicant Integra Lifesciences Production Corporation

K number K223330

JXG 2022-12-29

Reflow System Mini and ReFlow Mini Flusher

Applicant Anuncia Medical, Inc.

K number K223603

JXG 2022-12-08

IRRAflow Active Fluid Exchange System (AFES)

Applicant Irras USA

K number K222471

JXG 2022-10-14

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

Applicant Integra Lifesciences Production Corporation

K number K221840

JXG 2022-09-29

ReFlow System Mini

Applicant Anuncia Medical, Inc.

K number K221918

JXG 2021-09-16

StrataMR II Valves and Shunts

Applicant Medtronic Neurosurgery

K number K212641

JXG 2020-05-08

Ventricular Catheter

Applicant Aesculap, Inc.

K number K200950

JXG 2020-04-29

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Applicant Irras USA, Inc.

K number K200807

JXG 2019-11-21

M. Blue Adjustable Shunt System

Applicant Aesculap, Inc.

K number K192266

JXG 2019-11-15

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Applicant Irras USA, Ltd.

K number K192289

JXG 2019-10-11

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System

K number K191684

JXG 2019-07-05

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

Applicant Aesculap, Inc.

K number K190174

JXG 2018-11-20

CodMan Certas Plus Programmable Valve

Applicant Integra Lifesciences Corp.

K number K182265

JXG 2018-10-25

Codman Certas Plus Electronic Tool Kit

Applicant Integra Lifesciences Corp.

K number K181902

JXG 2018-10-01

StrataMR guider tool

Applicant Medtronic Neurosurgery

K number K181622

JXG 2018-07-13

IRRAflow CNS System

Applicant Irras, Inc.

K number K171880

JXG 2018-06-14

Smart External Drain (SED) System

K number K181301

JXG 2018-03-24

EKOS ultrasound EVD Device, EVD Control Unit

Applicant Btg International, Inc.

K number K172035

JXG 2017-11-14

Smart External Drain (SED) System

K number K172759

JXG 2017-11-09

Alivio Ventricular Catheter and Flusher System (Alivio System)

Applicant Alcyone Lifesciences, Inc.

K number K172006

JXG 2017-10-16

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag

K number K172537

JXG 2017-10-03

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

K number K172022

JXG 2017-08-31

SureFlo EVD Catheter

Applicant Arkis Biosciences, Inc.

K number K170599

JXG 2017-06-30

Smart External Drain (SED) System

K number K171586

JXG 2017-02-27

proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System

Applicant Aesculap, Inc.

K number K161853

JXG 2016-10-28

Codman EDS3 CSF External Drainage System

K number K162437

JXG 2016-10-27

Smart External Drain (SED) System

K number K161605

JXG 2016-09-22

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems

K number K161992

JXG 2016-04-07

StrataMR Valves and Shunts

Applicant Medtronic Neurosurgery

K number K152700

JXG 2016-03-14

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

K number K153041

JXG 2016-03-04

Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

K number K152897

JXG 2013-12-13

LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC

Applicant Moller Medical GmbH

K number K121248

JXG 2013-03-07

SHUNTCHECK

Applicant Neurodx Development, LLC

K number K123554

JXG 2013-02-13

MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

Applicant Medtronic Neurosurgery

K number K123524

JXG 2012-08-03

HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM

K number K122118

JXG 2012-05-24

AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM

Applicant Aesculap, Inc.

K number K120559

JXG 2012-02-16

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

Applicant Medos International SARL

K number K113526

JXG 2011-11-18

MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER

Applicant Medtronic Neurosurgery

K number K110560

JXG 2011-10-27

AESCULAP- MEITHKE SHUNT SYSTEM

Applicant Aesculap, Inc.

K number K110206

JXG 2011-10-17

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM

Applicant Medos International SARL

K number K112156

JXG 2011-07-07

HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS

K number K101381

JXG 2011-05-09

CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER

K number K110751

JXG 2011-02-18

HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM

K number K102961

JXG 2011-01-14

CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER

K number K102589

JXG 2010-11-09

AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM

Applicant Aesculap, Inc.

K number K103003

JXG 2010-01-22

OSV II LOW FLOW LOW PRO VALVE

K number K093968

JXG 2010-01-22

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE

Applicant Sophysa SA

K number K091328

JXG 2009-11-19

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM

Applicant Integra Lifesciences Corp.

K number K092395

JXG 2009-09-02

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

Applicant Medtronic Neurosurgery

K number K091312

JXG 2009-08-11

POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400

Applicant Sophysa SA

K number K090342

JXG 2009-06-02

CODMAN HAKIM MICRO II VALVE

K number K091346

JXG 2009-03-04

CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET

K number K090348

JXG 2008-11-20

STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836

Applicant Medtronic Neurosurgery

K number K083076

JXG 2008-11-06

OSV II

K number K081773

JXG 2008-08-27

STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635

Applicant Medtronic Neurosurgery

K number K082127

JXG 2008-08-12

NEUROCATH AG

Applicant Vygon Neuro

K number K081942

JXG 2008-05-16

SHUNTCHECK - CSF SHUNT FLOW DETECTOR

Applicant Neuro Diagnostic Devices

K number K080168

JXG 2008-01-30

SMALL LUMEN PERITONEAL CATHETER

Applicant Medtronic Neurosurgery

K number K073139

JXG 2007-12-07

LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030

K number K072929

JXG 2007-08-16

RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715

Applicant Medtronic Neurosurgery

K number K063836

JXG 2007-01-17

AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T

Applicant Aesculap, Inc.

K number K062009

JXG 2006-10-16

CODMAN VPV SYSTEM, MODEL 82-3192

K number K061876

JXG 2006-09-29

CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

K number K061568

JXG 2006-09-27

MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS

K number K062599

JXG 2006-09-15

MEDTRONIC PS MEDICAL STRATA TYPE VALUE

Applicant Medtronic Neurosurgery

K number K060681

JXG 2006-01-19

MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS

K number K053350

JXG 2006-01-19

CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD

K number K053107

JXG 2005-12-16

MEDTRONIC M2 MAGNET ADJUSTMENT TOOL

Applicant Medtronic Neurosurgery

K number K052386

JXG 2005-07-18

CODMAN VPV SYSTEM, MODEL 82-3192

K number K050739

JXG 2005-01-28

MEDTRONIC STRATAVARIUS

Applicant Medtronic Neurosurgery

K number K041992

JXG 2004-12-21

ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM

K number K042825

JXG 2004-12-14

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400

Applicant Sophysa SA

K number K042481

JXG 2004-11-17

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

Applicant Medical Designs, LLC

K number K042359

JXG 2004-11-02

SHUNTCHECK (PROMETHEUS 1)

Applicant Samuel Neff M.D.

K number K040021

JXG 2004-10-19

PS MEDICAL STRATA II VALVE

Applicant Medtronic Neurosurgery

K number K042465

JXG 2004-10-06

EQUI-FLOW VALVE AND SHUNT SYSTEM

K number K042558

JXG 2004-09-24

PS MEDICAL NEUROSURGICAL IMPLANTS

Applicant Medtronic Neurosurgery

K number K042198

JXG 2004-09-02

LOW FLOW OSV II HYDROCEPHALUS VALVE

K number K042192

JXG 2004-06-15

MEDTRONIC PS MEDICAL STRATA VALVE

Applicant Medtronic Neurosurgery

K number K040943

JXG 2004-06-10

MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI

K number K041296

JXG 2004-05-27

MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS

Applicant Vygon Us, LLC

K number K033704

JXG 2004-04-07

PHOENIX INFUSION CATHETER

Applicant Phoenix Biomedical

K number K033017

JXG 2004-02-26

MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM

K number K040201

JXG 2004-02-26

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB

Applicant Sophysa SA

K number K031097