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

    Chariot Guiding Sheath

    K Number: K150186 · Decision Jun 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    432
    Review Days
    129

    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
    Chariot Guiding Sheath
    K Number
    K150186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    January 27, 2015
    Decision Date
    June 5, 2015
    Product Code
    DYB
    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
    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 Boston Scientific Corp

    K Number Device Name
    K243245 IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
    K231328 LUX-Dx II (M302); LUX-Dx II+ (M312)
    K152853 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
    K150692 AXIOS Stent with Electrocautery Enhanced Delivery System
    K150303 XXL Vascular Balloon Dilatation Catheter
    K150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
    K141820 JAGWIRE HIGH PERFORMANCE GUIDWIRE
    K141344 EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
    K141335 EXPEL APD DRAINAGE CATHETER SYSTEM
    K141150 PTA BALLOON DILATATION CATHETER
    Search all 432 clearances from Boston Scientific Corp →