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510(k) Data Aggregation

    K Number
    K251207

    Validate with FDA (Live)

    Device Name
    Sangria™ Thrombectomy System
    Manufacturer
    Avantec Vascular Corporation
    Date Cleared
    2026-01-07

    (264 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K141617,K193197
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter.

    Device Description

    The Sangria™ Thrombectomy System (Sangria™ System) is a sterile, single-use, percutaneous, 14 Fr catheter-based system (single-piece construction) designed for the removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. The 14Fr, over-the-wire Catheter features a battery-operated handle with a slider that deflects the Catheter to target thrombus. A power switch on the handle activates rotation of the tip. Once activated, the tip rotates to break down the thrombus, which is then cleared proximally through the Catheter lumen and aspiration port into an external canister via vacuum aspiration. The Catheter is offered in a Straight Sheath configuration.

    AI/ML Overview

    N/A

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