BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VersaCross Connect™ Transseptal Dilator

    K Number: K251325 · Decision May 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    24
    Review Days
    30

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    Basic Information

    Device Name
    VersaCross Connect™ Transseptal Dilator
    K Number
    K251325
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Company, Inc.
    Date Received
    April 29, 2025
    Decision Date
    May 29, 2025
    Product Code
    DRE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRE Dilator, Vessel, For Percutaneous Catheterization

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    Other Clearances by Baylis Medical Company, Inc.

    K Number Device Name
    K241720 VersaCross Connect™ Transseptal Dilator
    K231227 SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
    K233647 VersaCross Connect™ Transseptal Dilator
    K213898 ProTrack Pigtail Wire
    K221351 Mechanical Guidewire
    K213582 Epicardial Access System
    K220414 VersaCross Connect Transseptal Dilator
    K201288 ExpanSure Large Access Transseptal Dilator
    K191546 Epicardial Access System
    K183632 Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
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