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510(k) Data Aggregation

    K Number
    K071634
    Device Name
    MODIFICATION TO:CONTOUR SE MICROSPHERES
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2007-07-12

    (27 days)

    Product Code
    HCG,KRD
    Regulation Number
    882.5950
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO:CONTOUR SE MICROSPHERES

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

    Contour SE Microspheres are indicated for the embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).

    Device Description

    Contour SE Microspheres are spherical-shaped polyvinyl alcohol embolic devices to provide targeted vascular occlusion or reduction of blood flow within targeted vessels. The product is packaged sterile syringe containing a 1 mL of or 2 mL of Contour SE Microsphere and 5 mL of saline. Each syringe is packaged in a sterile, peel-away barrier.

    Contour SE Microspheres are designated for smooth delivery through a variety of infusion catheters.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called Contour SET™ Microspheres (Syringe). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) summary states that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety and efficacy have been raised," regarding the comparison to predicate devices. However, it does not detail specific performance metrics, study designs, sample sizes, or ground truth establishment.

    Therefore, I cannot provide the requested information from this document.

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