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

    PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

    K Number: K060509 · Decision Jun 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    116

    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
    PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
    K Number
    K060509
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare Group
    Date Received
    February 27, 2006
    Decision Date
    June 23, 2006
    Product Code
    NYU
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NYU Catheter, Hemodialysis, Implanted, Coated

    Similar 510(k) Clearances

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

    PALINDROME H, SI, HSI CHRONIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Tyco Healthcare Group

    K Number Device Name
    K063536 POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING