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

    PERCUTANEOUS INTRODUCER SET

    K Number: K902275 · Decision Sep 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    23
    Review Days
    128

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    Basic Information

    Device Name
    PERCUTANEOUS INTRODUCER SET
    K Number
    K902275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Thomas Medical Products, Inc.
    Date Received
    May 21, 1990
    Decision Date
    September 26, 1990
    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

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    Other Clearances by Thomas Medical Products, Inc.

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    K101015 GUIDE CATHETERS AND ACCESSORIES
    K083269 CROSSOVER
    K081341 REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
    K072745 Y-GLIDE
    K043438 LARGE BORE SPLITTABLE INTRODUCER KIT
    K040713 MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
    K011727 TRANSSEPTAL NEEDLE/TROCAR
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