Shunt, Central Nervous System And Components

FDA product code JXG · 253 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5550
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-30 – 2026-06-23

JXG 1988-08-24

SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1

Applicant Pmt Corp.

K number K883114

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JXG 1988-07-14

H-H FLUSHING RESERVOIR

Applicant Holter-Hausner Intl.

K number K875287

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JXG 1988-05-31

TRI-FLOW CATHETER

Applicant Neurodynamics, Inc.

K number K875205

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JXG 1988-01-19

H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG

Applicant Holter-Hausner Intl.

K number K874508

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JXG 1987-09-18

CSF-FLOW CONTROL VALVE, ULTRA SMALL

Applicant Pudenz-Schulte Medical Research Corp.

K number K873247

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JXG 1987-06-12

HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS

Applicant American V. Mueller

K number K871685

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JXG 1987-05-22

CSF-CARDIAC/PERITONEAL CATHETER

Applicant Pudenz-Schulte Medical Research Corp.

K number K871752

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JXG 1987-05-01

H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS

Applicant Holter-Hausner Intl.

K number K870660

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JXG 1986-12-29

HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM

Applicant American V. Mueller

K number K864676

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JXG 1986-12-03

P-S MEDICAL CSF-SIPHON CONTROL DEVICE

Applicant Pudenz-Schulte Medical Research Corp.

K number K862907

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JXG 1986-08-12

BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.

Applicant Pudenz-Schulte Medical Research Corp.

K number K862303

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JXG 1986-08-12

CAMINO CSF DRAINAGE SYSTEM MODEL 040

Applicant Camino Laboratories, Inc.

K number K861961

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JXG 1986-08-01

EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS

Applicant Cordis Corp.

K number K862513

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JXG 1986-06-19

STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES

Applicant Cordis Corp.

K number K861377

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JXG 1986-01-10

EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID

Applicant Cordis Corp.

K number K855058

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JXG 1985-11-27

EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE

Applicant Cordis Corp.

K number K854474

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JXG 1985-11-27

HEYER-SCHULTE SYRINGO PERITONEAL SHUNT

Applicant American V. Mueller

K number K854049

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JXG 1985-09-18

H-H ATRIAL CATHETERS & PERITONEAL CATHETERS

Applicant Holter-Hausner Intl.

K number K853371

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JXG 1985-09-16

ACCU-FLO PRESSURE VALVE

Applicant Codman & Shurtleff, Inc.

K number K853215

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JXG 1985-09-11

H-H FIXATION & JOINING CONNECTORS

Applicant Holter-Hausner Intl.

K number K853369

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JXG 1985-09-11

H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT

Applicant Holter-Hausner Intl.

K number K853366

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JXG 1985-09-05

H-H FIFTH VENTRICLE

Applicant Holter-Hausner Intl.

K number K853365

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JXG 1985-09-05

H-H RICKHAM TYPE RESERVOIR

Applicant Holter-Hausner Intl.

K number K853364

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JXG 1985-09-03

H-H CRUCIFORM-SLIT VALVE

Applicant Holter-Hausner Intl.

K number K853363

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JXG 1985-09-03

H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER

Applicant Holter-Hausner Intl.

K number K853362

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JXG 1985-08-28

H-H VENTRICULAR CATHETERS & RESERVOIRS

Applicant Holter-Hausner Intl.

K number K853361

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JXG 1984-09-12

RADIONICS MINI & STANDARD SHUNT VALVE

Applicant Radionics, Inc.

K number K843132

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JXG 1984-04-19

P-S MEDICAL CSF-FLOW CONTROL VALVE-

Applicant P-S Medical

K number K841442

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JXG 1984-04-03

ONE-PIECE SHUNT

Applicant American Heyer Schulte

K number K834593

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JXG 1983-08-12

P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT

Applicant Pudenz-Schulte Medical Research Corp.

K number K831396

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JXG 1983-06-24

P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR

Applicant Pudenz-Schulte Medical Research Corp.

K number K831678

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JXG 1983-04-08

H-H IN-LINE VALVED CATHETER 2 TYPES

Applicant Holter-Hausner Intl.

K number K830894

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JXG 1983-03-09

P-S CSF-VENTRICULAR CATHETER, FLANGED

Applicant Pudenz-Schulte Medical Research Corp.

K number K823503

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JXG 1982-12-16

P-S MED. LUMBO PERITONEAL & VENTRICULO-

Applicant Pudenz-Schulte Medical Research Corp.

K number K823509

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JXG 1982-03-01

H-H RICKHAM TYPE RESERVOIR

Applicant Holter-Hausner Intl.

K number K820312

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JXG 1982-02-24

H-H BURR HOLE CATHETER SUPPORT

Applicant Holter-Hausner Intl.

K number K820311

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JXG 1982-02-18

EXTERNAL VENTRICULAR DRAINAGE SYS.

Applicant American Heyer Schulte

K number K820247

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JXG 1981-06-26

SPETZLER LUMBAR-PERITONEAL SYSTEM

Applicant American Heyer Schulte

K number K811288

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JXG 1981-01-22

CSG-FLOW CONTROL VALVE

Applicant Pudenz-Schulte Medical Research Corp.

K number K803257

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JXG 1980-12-18

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE

Applicant American Heyer Schulte

K number K802586

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JXG 1980-01-31

H-H FIFTH VENTRICLE

Applicant Holter-Hausner Intl.

K number K800168

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JXG 1980-01-16

CSF-VENTRICULAR CATHETER, STANDARD DES

Applicant Pudenz-Schulte Medical Research Corp.

K number K792007

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JXG 1980-01-16

CSF-CARDIAC/PERITONEAL CATHETER

Applicant Pudenz-Schulte Medical Research Corp.

K number K792005

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JXG 1979-08-03

H-H SLOTTED VENTRICULAR CATHETER

Applicant Holter-Hausner Intl.

K number K791076

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JXG 1979-08-03

H-H SLOTTED CATHETER-RESERVOIR

Applicant Holter-Hausner Intl.

K number K791075

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JXG 1979-05-11

H-H FIXATION AND JOINING CONNECTORS

Applicant Holter-Hausner Intl.

K number K790849

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JXG 1979-01-26

VALVE, H-H CRUCIFORM SLIT

Applicant Holter-Hausner Intl.

K number K790126

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JXG 1979-01-15

CATHETERS, H-H VENTRICULAR

Applicant Holter-Hausner Intl.

K number K782105

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JXG 1978-11-14

CATHETERS, H-H ATRIAL AND PERITONEAL

Applicant Holter-Hausner Intl.

K number K781768

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JXG 1976-11-01

MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH

Applicant Heyer Schulte Corp.

K number K760785

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JXG 1976-11-01

MISHLER 2 CHAMB FLUSHING VALVE,STAND

Applicant Heyer Schulte Corp.

K number K760784

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JXG 1976-08-30

VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.

Applicant Joe W. Utt

K number K760502

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JXG 1976-08-30

VALVE, STANDARD MODEL PUDENZE FLUSHING

Applicant Heyer Schulte Corp.

K number K760501

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