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

    Sapphire NC Plus Coronary Dilatation Catheter

    K Number: K192344 · Decision Sep 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    7
    Review Days
    21

    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
    Sapphire NC Plus Coronary Dilatation Catheter
    K Number
    K192344
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orbusneich Medical Trading, Inc.
    Date Received
    August 29, 2019
    Decision Date
    September 19, 2019
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

    Similar 510(k) Clearances

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

    Firefighter™ Pro PTCA Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLASH Flex™ Aorto-Ostial Angioplasty System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ryurei

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pantera Pro; Pantera LEO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sapphire NC ULTRA Coronary Dilatation Catheter

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

    Other Clearances by Orbusneich Medical Trading, Inc.

    K Number Device Name
    K200269 Sapphire II PRO
    K182713 Scoreflex PTA Scoring Balloon Catheter
    K182360 Teleport Microcatheter
    K180921 Sapphire II PRO Balloon Dilatation Catheter
    K173680 Sapphire II PRO
    K173894 Jade PTA Balloon Dilatation Catheter