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

    ProTrack RF Anchor Wire

    K Number: K150709 · Decision Jun 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    24
    Review Days
    90

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    Basic Information

    Device Name
    ProTrack RF Anchor Wire
    K Number
    K150709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5175
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Company, Inc.
    Date Received
    March 19, 2015
    Decision Date
    June 17, 2015
    Product Code
    DXF
    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
    DXF Catheter, Septostomy

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    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
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