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510(k) Data Aggregation

    K Number
    K251744

    Validate with FDA (Live)

    Device Name
    Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
    Manufacturer
    Medtronic
    Date Cleared
    2026-01-16

    (224 days)

    Product Code
    DTM
    Regulation Number
    870.4260
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    0.083 - 21
    Reference & Predicate Devices
    K171979,K100646,K071253
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Affinity® Pediatric Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

    The Affinity Pixie™ Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

    Device Description

    The Affinity Pixie™ Arterial Filter with Balance™ Biosurface and Affinity® Pediatric Arterial Blood Filter are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size, from the circuit for periods up to six (6) hours, during cardiopulmonary bypass surgery. The Affinity Pixie™ Arterial Filter with Balance™ Biosurface device is coated with a non-leaching biocompatible surface to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The Affinity® Pediatric Arterial Blood Filter is uncoated. The models listed above will be referred to as Affinity Pixie™ Arterial Filter throughout the submission.

    AI/ML Overview

    N/A

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