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

    PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM

    K Number: K880072 · Decision Mar 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    43
    Review Days
    78

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    Basic Information

    Device Name
    PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
    K Number
    K880072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharmacia Deltec, Inc.
    Date Received
    January 11, 1988
    Decision Date
    March 29, 1988
    Product Code
    LLD
    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
    LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal

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    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. →