BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

    K Number: K092014 · Decision Oct 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    8
    Review Days
    94

    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
    SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
    K Number
    K092014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Onset Medical Corporation
    Date Received
    July 6, 2009
    Decision Date
    October 8, 2009
    Product Code
    DYB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DYB Introducer, Catheter

    Similar 510(k) Clearances

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

    FieldFlex Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Echo Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Introducer Sheath Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards eSheath+ introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aventus Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Protaryx Transseptal Puncture Device (PTX2-001)

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

    Other Clearances by Onset Medical Corporation

    K Number Device Name
    K152498 SoloPath Re-Collapsible Access System
    K121404 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
    K112629 ONSET ACCESS CATHETER SYSTEM
    K100819 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
    K062852 BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
    K061009 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
    K043254 PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH