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510(k) Data Aggregation

    K Number
    K240078
    Device Name
    Fogarty Thru-Lumen Embolectomy Catheter
    Manufacturer
    Edwards Lifesciences, LLC
    Date Cleared
    2024-08-28

    (230 days)

    Product Code
    DXE, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.
    Device Description
    The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.
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    K Number
    K241330
    Device Name
    Fogarty Fortis Arterial Embolectomy Catheter
    Manufacturer
    Edwards Lifesciences
    Date Cleared
    2024-07-02

    (53 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.
    Device Description
    The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearing emboli and thrombi from vessels in the arteries of the peripheral system through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 4F and are available in 40 cm and 80 cm lengths. The device consists of a radiopaque catheter shaft with an integrated elastomeric latex balloon and an atraumatic tip that is inserted surgically into arterial vessels of the peripheral system. A hub at the proximal end is used for balloon inflation.
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    K Number
    K233819
    Device Name
    Fogarty Venous Thrombectomy Catheters
    Manufacturer
    Edwards Lifesciences, LLC
    Date Cleared
    2024-05-22

    (173 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.
    Device Description
    Fogarty venous thrombectomy catheters are specifically designed for the performance of venous thrombectomy in adult patients. Fogarty venous thrombectomy catheters have a long, soft tip which is intended to facilitate advancement past the venous valves while minimizing trauma. The flexibility required for the venous procedure is supplied by the spring-wound body. The spring is covered with a braiding for additional strength. The gate valve is designed for single-handed operation and to minimize the possibility of leakage. The gate valve has an arrow to indicate the "open" and "closed" positions. There are three available catheter sizes (6 French (2.0 mm), 8 French (2.7 mm), and 8/10 French (2.7/3.3 mm)). Each may be quickly identified by the color-coded body. The size and filling capacity are printed on each catheter.
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    K Number
    K233820
    Device Name
    Fogarty Arterial Embolectomy Catheter with Gate Valve
    Manufacturer
    Edwards Lifesciences
    Date Cleared
    2024-05-22

    (173 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fogarty arterial embolectomy catheter with gate valve is indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial vasculature.
    Device Description
    The Fogarty Arterial Embolectomy Catheter with Gate Valve provides a means of clearing emboli and thrombi from vessels in the arteries of the peripheral vasculature through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 2F and is available in 45 cm length. The catheter contains a latex balloon at the distal end and a gate valve at the proximal end for connection to a syringe for balloon inflation.
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    K Number
    K233619
    Device Name
    Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
    Manufacturer
    Edwards Lifesciences
    Date Cleared
    2024-05-20

    (189 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts. The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.
    Device Description
    **Fogarty Corkscrew Catheters:** The Fogarty Corkscrew Catheters are sterile, single use flexible catheters consisting of a polyvinylchloride outer catheter body surrounding a movable, radiopaque stainless steel spring body. A second radiopaque, spiral-shaped, stainless steel cable covered by a latex membrane is attached to the distal end of the catheter. A handle to modulate the spiral cable diameter is attached to the inner spring body at the proximal end of the catheter. The spiral cable design of the Fogarty Corkscrew catheter increases the surface area for entrapping fibrous material. **Fogarty Graft Thrombectomy Catheters:** The Fogarty Graft Thrombectomy catheters are sterile, single use catheters designed to remove organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arterial vasculature fistulas for dialysis access and synthetic grafts for iliofemoral bypass. During use, the control button on the device handle is grasped and moved forward and aft to cause the spiral wires at the distal end to extend or retract. The spiral wires are extended during passage of the device through a narrowed region of a vessel. The spiral wires are then retracted to facilitate occlusive material removal.
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    K Number
    K213771
    Device Name
    Merlin Aspiration System
    Manufacturer
    MIVI Neurovascular, Inc.
    Date Cleared
    2022-01-27

    (56 days)

    Product Code
    DXE, QEZ
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Merlin Aspiration Catheter As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system. · High Flow Tubing As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
    Device Description
    The Merlin Aspiration System is comprised of two devices: - Merlin Aspiration Catheter - High Flow Tubing The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy. Merlin Aspiration Catheter The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558). High Flow Tubing The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.
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    K Number
    K202049
    Device Name
    Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
    Manufacturer
    Applied Medical Resources Corporation
    Date Cleared
    2021-09-07

    (410 days)

    Product Code
    DXE, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel. The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.
    Device Description
    The Python Embolectomy Catheter & Over-the-Wire Latis Graft Cleaning Catheters are sterile, single use vascular balloon catheters intended for use in the removal of thromboemboli, occlusion of vessels, and the infusion of fluids. The devices are intended for use in arterial vessels and artificial vascular grafts respectively. The body of the catheters utilize a dual lumen design with one inflation lumen used to inflate the balloon, and one through lumen allowing for insertion over a guide wire or infusion of fluids. The outer diameter of the body is designed to accommodate use with a standard percutaneous access sheath. The Over-the-wire Latis Graft Cleaning Catheter includes a braided mesh which surrounds the balloon and is designed to increase engagement with wall of artificial vascular graft.
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    K Number
    K193379
    Device Name
    Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
    Manufacturer
    Edwards Lifesciences, LLC
    Date Cleared
    2020-06-12

    (190 days)

    Product Code
    DXE, GCA
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended. Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.
    Device Description
    Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter consists of a catheter body tube made out of polyvinyl chloride (PVC) or nylon (3F only) of 40, 60, or 80 cm lengths. The catheter contains a latex balloon at the distal end and a PVC hub at the proximal end for connection to a syringe for balloon inflation. They contain a soft, rounded tip, which promotes easy arterial insertion. The model with an “S” has a stylet at the proximal end to support the inflation lumen during shipping and storage. These devices are provided sterile and labeled for single use only. Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe consists of a single-lumen polyvinyl chloride (PVC) catheter body with a latex balloon at the distal end. A hub at the proximal end is used for balloon inflation. A flexible stylet is provided with Fogarty Biliary Balloon Probe. The stylet is of a designed stiffness intended to avoid perforation and yet maintain enough shape to facilitate introduction of the probe into areas of sharp angulation. These devices are provided sterile and labeled for single use only. The Fogarty Biliary Balloon Probe is not intended to be used with other devices.
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    K Number
    K163031
    Device Name
    Bunegin-Albin Air Aspiration Set
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2017-07-27

    (269 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.
    Device Description
    The Bunegin-Albin Air Aspiration Set is comprised of an air aspiration catheter, wire guide, entry access needle, dilator, syringe, stopcock, and scalpel. The air aspiration catheter is manufactured from radiopaque extruded polyethylene tubing and is designed with a pre-molded winged fitting. The catheter is 5.8 French in size with an endhole diameter of 0.035 inches. The wire guide is manufactured from stainless steel coils, a safety wire, and a mandril wire. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. The set also includes a 12 cc syringe, a low pressure three way stopcock, and a scalpel. The Bunegin-Albin Air Aspiration Set is sterilized by ethylene oxide and intended for one-time use.
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    K Number
    K163353
    Device Name
    Needle's Eye Snare Retrieval Set - 54cm
    Manufacturer
    Cook Incorporated
    Date Cleared
    2017-07-11

    (223 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    DXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Needle's Eye Snare® Retrieval Set - 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
    Device Description
    The Needle's Eye Snare® Retrieval Set- 54cm is a grasping device that forms a basketlike snare around the in-dwelling catheter, cardiac lead, fragment of catheter tubing, wire guide or other foreign object. The distal end is delivered to the vicinity of the lead through a long, flexible 12Fr. (O.D.) PTFE sheath placed coaxially within a 16Fr. (O.D.) PTFE Check-Flo® Introducer Sheath having a Check-Flo® Valve with stopcock at its proximal end. The device is comprised at the distal end of a nitinol wire needle's eye retrieval mechanism consisting of a "needle's eye" loop and "threader" with stainless steel sleeves housed within a PTFE protective cover sheath. The snare is activated through the forward advancement of the threader by fully depressing the plunger. The item is captured between the threader and needle's eye. The inner sheath is advanced forward closing the snare and securely capturing the lead or other foreign object. The Needle's Eye Snare® Retrieval Set - 54cm has nominal usable length of 54cm.
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