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

    UltraScore™ Focused Force PTA Balloon

    K Number: K260012 · Decision Feb 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    44
    Applicant Total
    34
    Review Days
    30

    Basic Information

    Device Name
    UltraScore™ Focused Force PTA Balloon
    K Number
    K260012
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Peripheral Vascular, Inc.
    Date Received
    January 5, 2026
    Decision Date
    February 4, 2026
    Product Code
    PNO
    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
    PNO Catheter, Percutaneous, Cutting/Scoring

    Similar 510(k) Clearances

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

    Aperta NSE PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tri-Wedge PTA Scoring Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D·Kutting™ PTA Scoring Balloon Dilatation Catheter

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

    Other Clearances by Bard Peripheral Vascular, Inc.

    K Number Device Name
    K252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal System
    K250032 Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
    K250219 Dorado™ PTA Balloon Dilatation Catheter
    K243642 UltraCor™ Twirl™ Breast Tissue Marker
    K242757 Rotarex Atherectomy System
    K241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-
    K232737 PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port
    K221440 Liverty™ TIPS Access Set
    K211410 GlidePath 13F Long-Term Hemodialysis Catheter
    K192948 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
    Search all 34 clearances from Bard Peripheral Vascular, Inc. →