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510(k) Data Aggregation

    K Number
    K083855
    Device Name
    MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2009-02-17

    (55 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The SPIRIT™ Navigable Lead Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), to aid in positioning of the device in the vasculature.
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    K Number
    K080500
    Device Name
    MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2008-03-13

    (17 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.
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    K Number
    K070396
    Device Name
    MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2007-05-22

    (99 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.
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    K Number
    K070051
    Device Name
    ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2007-04-06

    (92 days)

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

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The Insight is intended for use in the right heart only.
    Device Description
    The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
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    K Number
    K070197
    Device Name
    ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2007-02-23

    (32 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acumen Lead Delivery Sheath with Stylet is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.
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    K Number
    K062145
    Device Name
    MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2006-08-23

    (27 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.
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    K Number
    K062084
    Device Name
    7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2006-08-18

    (28 days)

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

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 7F Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
    Device Description
    The 7F Acumen Coronary Sinus Visualization System (CSVS) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
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    K Number
    K053400
    Device Name
    ACUMEN SINGLE-LUMEN DELIVERY SHEATH
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2006-06-19

    (195 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.
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    K Number
    K051515
    Device Name
    MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2005-09-01

    (85 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Acumen Sheath has a guidewire lumen and a lumen for the introduction of various types of I he reading or defibrillator leads and catheters. The sheath is designed to be slittable, thereby allowing its removal from the lead, and a slitter is provided with the device.
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    K Number
    K050015
    Device Name
    MODIFIED ACUMEN SHEATH, MODEL TTWO767
    Manufacturer
    ACUMEN MEDICAL, INC.
    Date Cleared
    2005-02-03

    (30 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
    Device Description
    The Acumen Sheath is a single-use percutaneous catheter indicated for the introduction of various types of pacing or defibrillator leads and catheters. The Acumen Sheath has a guidewire lumen for the introduction of various types of pacing or defibrillator leads and catheters. The sheath is designed to be splittable, thereby allowing its removal from the lead, and a slitter is provided with the device.
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