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

    STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

    K Number: K053120 · Decision Dec 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    9
    Review Days
    32

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    Basic Information

    Device Name
    STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
    K Number
    K053120
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excelsior Medical Corp.
    Date Received
    November 7, 2005
    Decision Date
    December 9, 2005
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Excelsior Medical Corp.

    K Number Device Name
    K130975 SWABCAP AND SWABFLUSH
    K101270 SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
    K083508 SWABCAP
    K082837 STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
    K061497 SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
    K023740 SYREX PRE-FILLED SYRINGE
    K962938 EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
    K942349 MICROBORE EXTENSION SET