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510(k) Data Aggregation
K Number
K160223Device Name
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
Manufacturer
COOK INCORPORATED
Date Cleared
2016-04-08
(70 days)
Product Code
NHC
Regulation Number
882.4100Why did this record match?
Product Code :
NHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Device Description
The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation consists of a VentriClear® Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closed-end configuration with 16 standard and 16 small sideports. The VentriClear® Ventricular Drainage Catheter has markings at 1 cm increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.
The VentriClear® II Ventricular Drainage Catheter consists of a VentriClear® II Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® II Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closedend configuration with 16 sideports. The VentriClear® II Ventricular Drainage Catheter has markings at 1 cm increments, starting at the 3 cm mark and extending to 33 cm, to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® II Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.
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K Number
K071640Device Name
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
Manufacturer
COOK, INC.
Date Cleared
2007-07-12
(27 days)
Product Code
NHC
Regulation Number
882.4100Why did this record match?
Product Code :
NHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Device Description
Spectrum® VentriClear™ II Ventricular Drainage Catheter Set includes a silicone 2.8 mm (9 Fr.) ventricular catheter available in a 33 cm length with numbered markings and 16 sideports. VentriClear™ II is impregnated with minocycline and rifampin. This device is supplied sterile and is intended for one-time use.
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K Number
K011812Device Name
SPECTRUM VENTRICULAR CATHETER
Manufacturer
COOK, INC.
Date Cleared
2001-11-08
(150 days)
Product Code
NHC
Regulation Number
882.4100Why did this record match?
Product Code :
NHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPECTRUM® Ventricular Catheter is intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume. The device will be supplied sterile and is intended for one-time use.
Device Description
The SPECTRUM® Ventricular Catheter is a 9 Fr catheter nominally 33 cm in length. The catheter has a closed-end configuration with nominally 16 sideports, and has markings at 1 cm increments to aid in determining depth of placement. The SPECTRUM® Ventricular Catheter is impregnated with an antimicrobial combination of minocycline and rifampin which may reduce the risk of catheter related infection during use. Based on HPCC analysis, the average amount of minocycline on the catheter is approximately 5 mg (159 Φg/cm), and the average amount of rifampin on the catheter is approximately 4 mg (116 @g/cm). Components supplied with the SPECTRUM® Ventricular Catheter include a pre-loaded stainless steel stylet, a stainless steel tunneling trocar, and proximal fittings, which are included to facilitate placement and use of the Ventricular Catheter.
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