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

    PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM

    K Number: K994216 · Decision Jan 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    32
    Review Days
    43

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    Basic Information

    Device Name
    PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
    K Number
    K994216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sims Deltec, Inc.
    Date Received
    December 15, 1999
    Decision Date
    January 27, 2000
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Sims Deltec, Inc.

    K Number Device Name
    K010426 PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
    K000842 CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
    K000942 CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
    K992697 PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
    K992880 P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
    K991599 CADD ADMINISTRATION SET
    K991255 CADD-TPN ADMINISTRATION SET, MODEL 21-7071
    K991301 CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
    K990083 CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
    K984055 CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
    Search all 32 clearances from Sims Deltec, Inc. →