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510(k) Data Aggregation

    K Number
    K140034
    Device Name
    SUREFIRE GUIDING CATHETER
    Manufacturer
    SUREFIRE MEDICAL, INC.
    Date Cleared
    2014-02-26

    (50 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K110459,K121677,K122506,K030779
    Why did this record match?
    Reference Devices :

    K110459, K121677, K122506

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

    The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

    Device Description

    The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

    The Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.

    The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.

    The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

    The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

    AI/ML Overview

    This document describes the Surefire Guiding Catheter, a medical device, and its acceptance criteria as demonstrated through various studies.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text details various tests performed to demonstrate the safety and effectiveness of the Surefire Guiding Catheter and its equivalence to a predicate device. The acceptance criteria are implicitly met by the successful completion of these tests and the determination of substantial equivalence.

    Acceptance Criteria CategorySpecific Test / RequirementReported Device Performance
    BiocompatibilityISO 10993-1 (External communicating device,
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