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510(k) Data Aggregation

    K Number
    K252612
    Device Name
    INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing
    Manufacturer
    Penumbra, Inc.
    Date Cleared
    2025-10-16

    (58 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K242075,K222358,K241399,K242520,K240030
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    INDIGO Aspiration Catheters and Separators

    As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

    INDIGO Aspiration Tubing

    As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.

    Penumbra Aspiration Pump

    The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

    Device Description

    The INDIGO® Aspiration System is comprised of several devices:

    • INDIGO Aspiration Catheter
    • Penumbra Aspiration Pump
    • INDIGO Aspiration Pump Canister
    • INDIGO Aspiration Tubing
    • INDIGO Separator

    The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister.

    Lightning Flash and Lightning Bolt Aspiration Tubing:

    The Lightning Flash and Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating the transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.

    AI/ML Overview

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