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

    ExpanSure Transseptal Dilation System

    K Number: K182064 · Decision Mar 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    24
    Review Days
    232

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ExpanSure Transseptal Dilation System
    K Number
    K182064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Company, Inc.
    Date Received
    August 1, 2018
    Decision Date
    March 21, 2019
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRE), ordered by most recent decision date.

    ProtekDilate Vascular Access Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross Connect™ Transseptal Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Micro Ace Gold Advanced Micro Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross Connect™ Transseptal Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross Connect™ Transseptal Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Micro Ace™ Advanced Micro Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Baylis Medical Company, Inc.

    K Number Device Name
    K251325 VersaCross Connect™ Transseptal Dilator
    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
    Search all 24 clearances from Baylis Medical Company, Inc. →