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510(k) Data Aggregation

    K Number
    K242337
    Device Name
    FlowGuide (FG60F); GuidionShort (GS60F)
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2025-04-17

    (253 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.
    Device Description
    The FlowGuide and GuidionShort are single lumen rapid exchange catheters being compatible with 6F and larger guide catheters and may be placed over either an exchange length or 180cm guide wire. The 150cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The catheters have a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively. The catheters are delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The catheters have a proximal hub which indicates guide catheter compatibility. The FlowGuide has 9 perfusion holes in the distal shaft intended to reduce pressure dampening.
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    K Number
    K241611
    Device Name
    ShapeIT (SI014135)
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2024-09-03

    (90 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ShapelT catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature. The device is contraindicated for use in the neurovasculature.
    Device Description
    The ShapelT is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The ShapelT is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The ShapeIT distal end is preshaped to support guidewire redirection in bifurcations. The ShapelT catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.
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    K Number
    K223728
    Device Name
    Micro Rx
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2023-07-13

    (212 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Rx catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature. The device is contraindicated for use in the neurovasculature.
    Device Description
    The Micro Rx is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The Micro Rx is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The Micro Rx catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.
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    K Number
    K210431
    Device Name
    ReCross
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2021-07-15

    (153 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.
    Device Description
    The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014" Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port. To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen
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    K Number
    K210110
    Device Name
    Guidion
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2021-03-31

    (71 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Guidion catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices.
    Device Description
    The Guidion catheter is a single lumen rapid exchange catheter offered in sizes being compatible with 5F; 6F; 7F and 8F guide catheters and may be placed over an guide wire. The 150cm long device has a stainless steel shaft section. The stainless steel shaft is followed distally by a 25cm lumen section. The Guidion catheter has a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively. The Guidion catheter is delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The Guidion catheter has a proximal hub which indicates guide catheter compatibility.
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    K Number
    K200324
    Device Name
    NHancer Rx
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2020-08-06

    (178 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.
    Device Description
    The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014" Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014"/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen. To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the entire lumens of the NHancer Rx are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen
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    K Number
    K191229
    Device Name
    TrapIt
    Manufacturer
    IMDS Operations B.V.
    Date Cleared
    2020-01-21

    (258 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS Operations B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter.
    Device Description
    The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.
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    K Number
    K121077
    Device Name
    NHANCER
    Manufacturer
    IMDS OPERATIONS B.V.
    Date Cleared
    2012-12-21

    (256 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMDS OPERATIONS B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.
    Device Description
    The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).
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