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

    HEMOSTATIC Y CONNECTOR

    K Number: K911130 · Decision Jun 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    23
    Review Days
    84

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    Basic Information

    Device Name
    HEMOSTATIC Y CONNECTOR
    K Number
    K911130
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Thomas Medical Products, Inc.
    Date Received
    March 14, 1991
    Decision Date
    June 6, 1991
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    K083269 CROSSOVER
    K081341 REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
    K072745 Y-GLIDE
    K043438 LARGE BORE SPLITTABLE INTRODUCER KIT
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