Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083776
    Manufacturer
    Date Cleared
    2009-03-05

    (76 days)

    Product Code
    Regulation Number
    876.5980
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S

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

    The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

    Device Description

    CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device: CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S.

    **This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

    The letter is a regulatory document confirming that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application (PMA). This determination is based on the safety and effectiveness information submitted in the 510(k) premarket notification, but the letter itself does not describe the specific studies or data generated to support that substantial equivalence. These details would typically be found in the original 510(k) submission itself if it were publicly available.

    Therefore, I cannot provide the requested table and information based on the text provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1