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

    CADD-TPN(TM) AMBULATORY INFUSION SYSTEM

    K Number: K931113 · Decision Apr 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    43
    Review Days
    420

    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
    CADD-TPN(TM) AMBULATORY INFUSION SYSTEM
    K Number
    K931113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmacia Deltec, Inc.
    Date Received
    March 4, 1993
    Decision Date
    April 28, 1994
    Product Code
    FIH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIH Pump, Infusion Or Syringe, Extra-Luminal

    Similar 510(k) Clearances

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

    PERCUPUMP II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VECTOR AMBULATORY DRUG DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTROCULAR FLUID INJECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Pharmacia Deltec, Inc.

    K Number Device Name
    K943310 MODEL 6100 AMBULATORY INFUSION SYSTEM
    K942046 PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE
    K942161 LOCKBOX
    K942024 PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
    K941445 EXTENSION SET WITH ANTI-SIPHON VALVE
    K931073 CATH-FINDER
    K932430 DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER
    K932433 PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE
    K932198 PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
    K932464 PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.
    Search all 43 clearances from Pharmacia Deltec, Inc. →