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

    PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E

    K Number: K001102 · Decision Apr 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    4
    Review Days
    15

    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
    PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
    K Number
    K001102
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rd Medical Mfg., Inc.
    Date Received
    April 5, 2000
    Decision Date
    April 20, 2000
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

    Similar 510(k) Clearances

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

    iiSure Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PuraCath Firefly Needleless Connector IT (9005)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Pump Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZ™ IV Administration Set

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

    Other Clearances by Rd Medical Mfg., Inc.

    K Number Device Name
    K010538 PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
    K000017 PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
    K992104 PARSET, MODEL A10001E