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510(k) Data Aggregation

    K Number
    K251014
    Device Name
    APRO 45 Catheter
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-05-01

    (29 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 45 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 45 Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 45 Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 45 Catheter is provided with an Introducer Sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
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    K Number
    K251015
    Device Name
    APRO 45 Catheter and Alembic Aspiration Tubing
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-04-30

    (28 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 45 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.
    Device Description
    The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 45 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives. The Alembic Aspiration Tubing connects the APRO 45 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
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    K Number
    K250962
    Device Name
    APRO 55 Intermediate Catheter
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-04-29

    (29 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 55 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Intermediate Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The catheter is provided with an Introducer Sheath.
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    K Number
    K250958
    Device Name
    APRO 55 Swift Catheter and Alembic Aspiration Tubing
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-04-28

    (28 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 55 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 55 Swift Catheter to the aspiration pump.
    Device Description
    The APRO 55 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove thrombus from the vasculature using aspiration. It targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature, guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation, and a radiopaque marker is at the distal end for fluoroscopic visualization. It is used with an aspiration pump connected via the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The catheter is available in lengths of 125 cm and 137 cm and is supplied with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 55 Swift Catheter to the aspiration pump and features a flow control valve with an ON/OFF switch. It is available in a single size.
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    K Number
    K243287
    Device Name
    APRO 70 Swift Catheter and Alembic Aspiration Tubing
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-02-24

    (129 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 70 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 70 Swift Catheter to the aspiration pump.
    Device Description
    The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Swift Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Swift Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Swift Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 70 Swift Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
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    K Number
    K243297
    Device Name
    APRO 70 Swift Catheter
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-01-14

    (88 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 70 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 70 Swift Catheter is provided with an Introducer Sheath.
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    K Number
    K234115
    Device Name
    APRO 55 Catheter
    Manufacturer
    Alembic, LLC
    Date Cleared
    2024-03-15

    (79 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 55 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 55 Catheter is provided with an Introducer Sheath.
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    K Number
    K232971
    Device Name
    APRO 55 Catheter and Alembic Aspiration Tubing
    Manufacturer
    Alembic, LLC
    Date Cleared
    2024-02-29

    (161 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 55 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 Alembic Aspiration Tubing is intended to connect the APRO 55 Catheter to the aspiration pump.
    Device Description
    The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 55 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 55 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 55 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 55 Catheter is available in lengths of 125 cm and 137 cm and is provided with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 55 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
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    K Number
    K230695
    Device Name
    APRO 70 Catheter and Alembic Aspiration Tubing
    Manufacturer
    Alembic, LLC
    Date Cleared
    2023-04-10

    (28 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
    Device Description
    The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
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    K Number
    K223545
    Device Name
    APRO 70 Catheter and Alembic Aspiration Tubing
    Manufacturer
    Alembic, LLC
    Date Cleared
    2023-02-17

    (84 days)

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

    Alembic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
    Device Description
    The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath. The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
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