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510(k) Data Aggregation

    K Number
    K242289
    Device Name
    Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2025-03-21

    (231 days)

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

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter. The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.
    Device Description
    The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel. The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.
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    K Number
    K243593
    Device Name
    AXS Lift Intracranial Base Catheter
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2025-02-18

    (90 days)

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

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXS Lift Intracranial Base Catheter is introduction of interventional devices into the peripheral and neurovasculature.
    Device Description
    The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end. The distal end of the catheter contains bovine derived tallow. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.
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    K Number
    K241637
    Device Name
    Echo Intracranial Base Catheter
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2024-12-19

    (195 days)

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

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Echo Intracranial Base Catheter is indicated for the introduction of interventional devices into the neurovasculature.
    Device Description
    The Echo Intracranial Base Catheter is a single lumen, flexible, variable stiffness catheter with a 0.100 inch inner diameter, designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the neurovascular system. It has a radiopaque marker band on the distal end a luer hub at the proximal end. The distal catheter shaft has a 14 cm lubricious coating to reduce friction during use. It is packaged with a dilator and two rotating hemostatic valves. The Echo Intracranial Base Catheter is compatible with introducer sheaths with an inner diameter of 9F or greater. The Echo Intracranial Base Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
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    K Number
    K241768
    Device Name
    Broadway 8 Catheter (BRW084132-01)
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2024-12-19

    (182 days)

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

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Broadway 8 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.
    Device Description
    The Broadway 8 Catheter is a single lumen, flexible, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The Broadway 8 Catheter shaft has a lubricious hydrophilic coating at the distal end to reduce friction during use. It is packaged with a FastPass Delivery Assist Catheter, two rotating hemostasis valves (RHVs) and two peel-away introducer sheaths. The FastPass Delivery Assist Catheter may be used in conjunction with the Broadway 8 Catheter to facilitate the introduction of the Broadway 8 Catheter into distal vasculature and aid in navigation to distal anatomy. The FastPass Delivery Assist Catheter has a lubricious hydrophilic coating at the distal end to reduce friction during use.
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    K Number
    K223305
    Device Name
    Trevo NXT ProVue Retriever
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2023-03-29

    (153 days)

    Product Code
    POL, NRY
    Regulation Number
    882.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset. 2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke 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. 3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age ≥80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
    Device Description
    The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
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    K Number
    K222533
    Device Name
    Target Tetra Detachable Coils
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2022-12-14

    (114 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: - Intracranial aneurysms - . Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature
    Device Description
    Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra (Subject Device). All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils with the Tetrahedral shape, the distal end of the main coil is formed such that the diameter of the distal loop is approximately 75% that of the overall secondary outer diameter (OD) size.
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    K Number
    K211594
    Device Name
    Trevo Trak 21 Microcatheter
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2021-11-26

    (186 days)

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

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
    Device Description
    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a Luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.
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    K Number
    K212455
    Device Name
    InZone Detachment System
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2021-11-16

    (103 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
    Device Description
    Stryker Neurovascular's InZone® Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.
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    K Number
    K202752
    Device Name
    AXS Vecta 46 Intermediate Catheter
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2021-08-27

    (340 days)

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

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Internediate Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The AXS Vecta 46 Intermediate Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 46 Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal 25cm) to reduce friction during use. It is packaged with one hemostasis valve, and one peel-away introducer.
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    K Number
    K210502
    Device Name
    Trevo NXT ProVue Retriever
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2021-08-27

    (186 days)

    Product Code
    POL, NRY
    Regulation Number
    882.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset. 2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke 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. 3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age ≥80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
    Device Description
    The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
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