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510(k) Data Aggregation

    K Number
    K253799

    Validate with FDA (Live)

    Date Cleared
    2026-03-13

    (105 days)

    Product Code
    Regulation Number
    870.5175
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SafeSept RF Transseptal Guidewire is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept RF Transseptal Guidewire is intended for single use only.

    The SafeSept Transseptal Guidewire is used in conjunction with a transseptal introducer to create the primary puncture in the interatrial septum and to guidewire the dilator and introducer through the septum from the right side of the heart to the left side.

    Indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept RF Transseptal Guidewire is intended for single use only.

    Device Description

    The SafeSept RF Transseptal Guidewire is a sterile, 180 cm or 230cm long, 0.032" or 0.035" diameter nitinol guidewire specifically designed to provide access to the left atrium via the right atrium in the same manner as the SafeSept Needle Free Transseptal Guidewire. The distal end of the wire is configured in either a J-shape or retention curve with a rounded edge tip. The RF Transseptal Guidewire uses a maximum of 10 Watts of radiofrequency energy to cross the septum. Once across the fossa ovalis, the guidewire becomes atraumatic due to its curve shape. The guidewire features a radiopaque coil that transitions to the nitinol wire. The guidewire has echogenic markers located along the shaft proximal to the radiopaque coil, which aid in visual guidance during transseptal procedures. The proximal end of the wire has laser-etched markings, which help determine the location of the guidewire tip relative to the introducer. When the wire is no longer supported, it is atraumatic and operates as a typical guidewire. The RF Transseptal Guidewire is used in conjunction with a monopolar electrosurgical generator or radiofrequency (RF) generator with selectable power settings in watts such as the Valleylab Force FX Electrosurgical Generator.

    The components of the SafeSept RF Transseptal Guidewire include the RF Transseptal Guidewire, dispenser and straightener, adapter clip, and sterile packaging and labeling. The model numbers of the subject device are SSRF132, SSRF132R, SSRF135, SSRF135R, SSRF232, SSRF232R, SSRF235, and SSRF235R. The SafeSept RF Transseptal Guidewire is sterilized by 100% ethylene oxide cycle and is for single use only.

    AI/ML Overview

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