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Regulation Number

Intended Use

These devices are intended as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes.

Device Description

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K Number

K030468

Device Name

ACURA ELITE GRAVITY COMPENSATING RESERVOIR

Manufacturer

Date Cleared

2003-10-15

(245 days)

Product Code

Regulation Number

Intended Use

This device is intended for implantation over either right or left frontal horn, in conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.

Device Description

Accura Elite Gravity Compensating Reservoir

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K Number

K024040

Device Name

ACCURA ELITE SHUNT SYSTEM

Manufacturer

Date Cleared

2003-01-27

(52 days)

Product Code

Regulation Number

Intended Use

The Accura Elite Shunt System is intended for use as the principle of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.

Device Description

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K Number

K024101

Device Name

PHOENIX UNIVERSAL SHUNT SYSTEM

Manufacturer

Date Cleared

2003-01-27

(46 days)

Product Code

Regulation Number

Intended Use

The Universal Shunt System is intended for use as the principle pressure-regulating component of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.

Device Description

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K Number

K021644

Device Name

PERF (OMMAYA STYLE) RESERVOIRS

Manufacturer

Date Cleared

2002-08-06

(78 days)

Product Code

Regulation Number

Intended Use

- The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for ventricular drainage. - The Perf (Ommaya Style) Reservoir may be used to access the ventricles for the administration of chemotherapeutic agents and/or radioisotopes.

Device Description

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K Number

K002476

Device Name

LUMBOPERITONEAL SHUNT SYSTEM

Manufacturer

Date Cleared

2000-11-09

(90 days)

Product Code

Regulation Number

Intended Use

Device Description

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K Number

K000514

Device Name

RUMBAR DRAINAGE SYSTEM

Manufacturer

Date Cleared

2000-05-10

(84 days)

Product Code

Regulation Number

Intended Use

Device Description

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K Number

K991429

Device Name

DIAMOND II VALVE

Manufacturer

Date Cleared

1999-05-19

(23 days)

Product Code

Regulation Number

Intended Use

This device is intended as the principle pressure regulating component of a CSF shunt assembly, used regulabing compt of hydrocephalus.

Device Description

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K Number

K990256

Device Name

CRX WORLD SHUNT

Manufacturer

Date Cleared

1999-04-01

(64 days)

Product Code

Regulation Number

Intended Use

Not Found

Device Description

The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.

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K Number

K974096

Device Name

CRX DIAMOND VALVE

Manufacturer

Date Cleared

1998-12-08

(404 days)

Product Code

Regulation Number