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510(k) Data Aggregation

    K Number
    K973216
    Device Name
    FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
    Manufacturer
    RMDS, INC.
    Date Cleared
    1997-11-25

    (90 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)

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

    The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.

    Device Description

    FAVC-HH: Femoral Artery Vascular Clamp-Hand Held

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Femoral Artery Vascular Clamp-Hand Held (FAVC-HH)". This document focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial data as requested in your prompt.

    Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to previously marketed devices and outlines regulatory requirements, but it does not detail the scientific studies or performance metrics for the FAVC-HH.

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