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

    THEREX LOW-PROFILE PORT

    K Number: K934792 · Decision Mar 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    26
    Review Days
    167

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    Basic Information

    Device Name
    THEREX LOW-PROFILE PORT
    K Number
    K934792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Therex Corp.
    Date Received
    October 6, 1993
    Decision Date
    March 22, 1994
    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 Therex Corp.

    K Number Device Name
    K953110 LOW PROFILE TITANIUM MODEL CATALOG #1003
    K953017 LOW PROFILE TITANIUM MODEL CATALOG #1003
    K952537 THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.
    K950212 A2 DETACHED DUAL PORT SYSTEM
    K950131 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL
    K942412 THEREX LOW-PROFILE PORT - TITANIUM MODEL
    K936012 THEREX LOW PROFILE PORT-TITANIUM MODEL
    K934802 THEREX LOW-PROFILE PORT-TITANIUM
    K933316 THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM
    K933350 THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM
    Search all 26 clearances from Therex Corp. →