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510(k) Data Aggregation

    K Number
    K254114

    Validate with FDA (Live)

    Device Name
    Baylis Connector Cable
    Manufacturer
    Baylis Medical Technologies, Inc.
    Date Cleared
    2026-01-18

    (30 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K230571
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Baylis Connector Cable is intended to connect Baylis Radiofrequency (RF) Puncture generators to separately cleared compatible RF devices.

    Device Description

    The Baylis Connector Cable is a sterile, single-use device designed to connect Baylis-approved Radiofrequency (RF) generators (including the PrecisePath RF Puncture Generator and RFP-100A Generator) to separately cleared compatible RF devices (e.g., RF guidewires).

    The Baylis Connector Cable is 10 feet long with a multi-pin positive locking Generator Connector at one end and a spring-loaded wire connection connector at the other end which allows connection to the RF delivery device. Between the connector ends is a single insulated conductor cable.
    Principle of Operation: Enables RF power transfer from generator to RF puncture device; no changes from predicate device.

    AI/ML Overview

    N/A

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