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510(k) Data Aggregation

    K Number
    K250012
    Device Name
    Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2025-02-26

    (55 days)

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

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Millipede 070 Aspiration Catheter The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. Perfuze Aspiration Tube Set The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
    Device Description
    The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
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    K Number
    K240711
    Device Name
    Zipline Access Catheter
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2024-10-17

    (216 days)

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

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
    Device Description
    The Zipline Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. It is available in two sizes: Zipline 070. Zipline 070. Zipline 088 is designed for use with outer catheters with 0.088" or larger internal diameter, and Zipline 070 is designed for use with outer catheters with 0.070" or larger internal diameter. During use, the Zipline Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline Access Catheter to the desired location. The Zipline Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopague marker at its distal end. Proximal to the tapered section is a "bulb" and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation. The Zipline Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018" in diameter.
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    K Number
    K242504
    Device Name
    Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2024-09-20

    (29 days)

    Product Code
    NRY, MAN, QJP
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Millipede 088 Access Catheter: The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. Millipede 070 Aspiration Catheter: The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Perfuze Aspiration Tube Set: The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
    Device Description
    Millipede 088 Access Catheter: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter. Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set: The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a RHV. The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
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    K Number
    K233648
    Device Name
    Millipede 088 Access Catheter
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2023-12-14

    (30 days)

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

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
    Device Description
    The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
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    K Number
    K232524
    Device Name
    Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2023-10-18

    (61 days)

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

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
    Device Description
    The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
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    K Number
    K231802
    Device Name
    Millipede 088 Access Catheter
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2023-09-19

    (91 days)

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

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
    Device Description
    The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
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    K Number
    K214048
    Device Name
    Millipede 088 Access Catheter
    Manufacturer
    Perfuze Ltd.
    Date Cleared
    2022-09-20

    (267 days)

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

    Perfuze Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
    Device Description
    The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
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