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

    MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES

    K Number: K092491 · Decision Feb 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    174

    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
    MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
    K Number
    K092491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medefil, Inc.
    Date Received
    August 13, 2009
    Decision Date
    February 3, 2010
    Product Code
    NZW
    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
    NZW Heparin, Vascular Access Flush

    Similar 510(k) Clearances

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

    BD PosiFlush Heparin Lock Flush Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEPARIN LOCK / FLUSH SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYREX PRE-FILLED SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Medefil, Inc.

    K Number Device Name
    K121262 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
    K091583 MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
    K020996 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
    K020999 MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
    K993518 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL
    K993515 MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L