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510(k) Data Aggregation

    K Number
    K161731
    Device Name
    Cleveland Multiport Ventricular Catheter Set
    Manufacturer
    Parker Hannifin Corp.
    Date Cleared
    2017-03-27

    (277 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
    Device Description
    The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
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    K Number
    K123605
    Device Name
    SMARTFLOW CATHETER
    Manufacturer
    MRI INTERVENTIONS, INC.
    Date Cleared
    2013-08-16

    (268 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartFlow™ Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."
    Device Description
    The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing. The Catheter will be marketed in the following sizes: Ventricular Catheter .008 x 7.5mm tip Ventricular Catheter .008 x 15mm tip Ventricular Cathcter .021 x 7.5mm tip Ventricular Catheter .021 x 15mm tip Each unit will provide for an approximate 23 inch tubing extension.
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    K Number
    K031123
    Device Name
    CODMAN BACTISEAL BARIUM STRIPED CATHETERS
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2003-05-14

    (35 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
    Device Description
    Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.
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    K Number
    K021481
    Device Name
    BRESAGEN CATHETER, MODEL CS-3000
    Manufacturer
    BRESAGEN, INC.
    Date Cleared
    2002-08-06

    (90 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.
    Device Description
    Bresagen Catheter, Model CS-3000
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    K Number
    K020728
    Device Name
    MIETHKE SHUNT SYSTEM
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2002-04-05

    (30 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
    Device Description
    The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.
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    K Number
    K013005
    Device Name
    ACT 11 MP VENTRICULAR CATHETER
    Manufacturer
    INNERSPACE, INC.
    Date Cleared
    2002-03-08

    (183 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in patients is required and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.
    Device Description
    The ICP monitor uses a bolt anchored in the skull. The bolt holds an air-column catheter with a flaccid bladder on the distal end. The proximal end of the catheter is attached to a pressure transducer placed in the distal end of a standard cable. The cable can be attached directly to any patient monitor. The ICP monitoring technology is based on Boyle's law. The bladder volume changes to accommodate PTV =P2V2 The pressure in the bladder, catheter and transducer thereby mirrors that of ICP. The air required to activate the bladder is introduced into the bladder when a piston on the proximal end of the catheter is joined to a cylinder on the transducer housing. The bladder air is replaced once per shift by removing and replacing the transducer housing on the piston. A probe guide is incorporated into the cap placed on the bolt at the factory and into the cap that accompanies the drainage catheter. The guides direct the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain but stops just above the drill hole. Both caps provide a compression fitting that secures and seals the probe to the cap. The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system. The bolt provides an access port through which a ventricular catheter can be introduced if drainage is needed. Should drainage of CSF be indicated, the top cap of the bolt is removed and the ACT II Ventricular Catheter is inserted into a ventricle. Once the catheter is in place, a preinstalled elastomeric sleeve and compression cap are moved down the catheter to the bolt. The cap compresses the sleeve against the bolt and catheter anchors the catheter in place.
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    K Number
    K003322
    Device Name
    CODMAN BACTISEAL CATHETERS
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2001-10-01

    (342 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992796
    Device Name
    ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    1999-10-25

    (67 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the Aspiration or Irrigation of fluids during Intracranial procedures. This device is not intended for implant
    Device Description
    Aspiration/Irrigation Catheter
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    K Number
    K983331
    Device Name
    MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
    Manufacturer
    MEDTRONIC PS MEDICAL
    Date Cleared
    1998-12-16

    (85 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Product Code :

    HCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.
    Device Description
    The Medtronic PS Medical Innervision Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter incorporates a BioGlide surface modification on the interior and exterior of the catheter. The catheter incorporates a slit tip.
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