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510(k) Data Aggregation

    K Number
    K251783

    Validate with FDA (Live)

    Date Cleared
    2025-12-22

    (194 days)

    Product Code
    Regulation Number
    870.4400
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K130433, K122844

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Inspire HCR and Inspire HCR DUAL cardiotomy reservoir are a device allowing suction blood recovery during extracorporeal circulation procedures, by providing blood collection and storage.

    In addition, the device supports extracorporeal system priming and defoams and filters suctioned blood. The Inspire HCR must be used up to 6 hours or less.

    Device Description

    The Inspire HCR and Inspire HCR DUAL cardiotomy reservoirs are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

    They are made by clear rigid shell reservoir (hard shell reservoirs), with suction/vent inlet and accessory connectors on the lid, and outlet connector on the bottom. These devices integrate a defoaming body, a filter, and a storage capacity function.

    They are devices allowing suction blood recovery during extracorporeal circulation procedures, by providing blood collection and storage. In addition, they support extracorporeal system priming, they defoam and filter suctioned blood. These cardiotomy reservoirs must be used up to 6 hours or less.

    The Inspire HCR and Inspire HCR DUAL cardiotomy reservoir are the modified version of the hard-shell reservoirs of the Inspire 8 and 8F hollow fiber oxygenator with integrated hardshell reservoir (Inspire HVR) (K130433) and the Inspire 8F dual hollow fiber oxygenator with integrated arterial filter and dual chamber hardshell venous/cardiotomy reservoir (Inspire HVR DUAL) (K122844).

    AI/ML Overview

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