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510(k) Data Aggregation

    K Number
    K233702
    Device Name
    SMARxT Tubing and Connectors
    Manufacturer
    Livanova USA Inc
    Date Cleared
    2024-08-08

    (265 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
    Device Description
    The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.
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    K Number
    K150542
    Device Name
    Terumo Pump Tubing
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Date Cleared
    2015-05-01

    (59 days)

    Product Code
    DWE, DWF
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
    Device Description
    The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP). The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal). The 68D PVC Pump Tubing will have a Shore A nominal durometer of 68D while the predicate device, the 70D PVC Pump Tubing, has a Shore A nominal durometer of 70D. The durometer dictates the hardness of the tubing. There are no internal markings on the subject tubing. Outside markings consist of the Terumo symbol, followed by inner diameter (in inches) x wall thickness (in inches), durometer, and TCVS part number.
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    K Number
    K142607
    Device Name
    AngioVac Circuit
    Manufacturer
    ANGIODYNAMICS
    Date Cleared
    2014-12-11

    (87 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
    Device Description
    The AngioVac Circuit is an extracorporeal perfusion set that includes four subassemblies including a main perfusion circuit (manufactured of 0.375" non-DEHP PVC coextruded tubing with Y-connector, tubing quick-connects and priming line), waste line, tuohy adapter and reinfusion cannula connector. An extra reinfusion cannula connector and tuohy adapter are provided in a sealed pouch with the circuit.
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    K Number
    K092486
    Device Name
    VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
    Manufacturer
    VORTEX MEDICAL INC
    Date Cleared
    2009-08-28

    (15 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
    Device Description
    The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").
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    K Number
    K080592
    Device Name
    HLM TUBING SET WITH BIOLINE COATING
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Date Cleared
    2008-09-11

    (192 days)

    Product Code
    DWE, DTL, DWF
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
    Device Description
    The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and it's components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
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    K Number
    K053025
    Device Name
    JOSTRA HLM TUBING SET
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Date Cleared
    2005-11-10

    (14 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less. The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
    Device Description
    The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours. Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit. The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter. The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.
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    K Number
    K022857
    Device Name
    PUMP TUBING WITH X-COATING
    Manufacturer
    Terumo Cardiovascular Systems Corporation
    Date Cleared
    2002-09-19

    (22 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
    Device Description
    Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC). Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.
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    K Number
    K013578
    Device Name
    PUMP TUBING
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Date Cleared
    2002-01-22

    (85 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. The tubing is intended for use in procedures lasting up to 6-hours in duration.
    Device Description
    Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.
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    K Number
    K993189
    Device Name
    CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
    Manufacturer
    TERUMO CORP.
    Date Cleared
    2000-03-01

    (160 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
    Device Description
    Cardiopulmonary Bypass Pump Tubing
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    K Number
    K993062
    Device Name
    CHEST DRAINAGE TUBING
    Manufacturer
    OLSON MEDICAL SALES, INC.
    Date Cleared
    1999-12-10

    (88 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Product Code :

    DWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.
    Device Description
    The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".
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