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510(k) Data Aggregation

    K Number
    K260043

    Validate with FDA (Live)

    Device Name
    Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
    Manufacturer
    Smart Reactors
    Date Cleared
    2026-02-23

    (47 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    18 - 999
    Reference & Predicate Devices
    K171979
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Circuit Tubing Set is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures for ≤ 6 hours.

    Device Description

    The Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing is a tubing pack intended for use during cardiopulmonary bypass. The tubing is DOP free polyvinylchloride (PVC) with an inner diameter of 9.5mm coated with Smart Reactors' proprietary Camouflage coating provided in a length of 180cm.

    This device is intended for use in the adult patient population.

    AI/ML Overview

    N/A

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