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

    PBC IV SET NON-VENTED

    K Number: K834253 · Decision Feb 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    11
    Review Days
    82

    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
    PBC IV SET NON-VENTED
    K Number
    K834253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Philadelphia Biologics Center
    Date Received
    December 7, 1983
    Decision Date
    February 27, 1984
    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 Philadelphia Biologics Center

    K Number Device Name
    K841717 INTRAVENOUS INJECTION SET
    K834256 PBC SYRINGE IRRIGATING
    K834255 PBC SCALP VEIN SET
    K834254 PBC IV SET VENTED
    K834252 PBC EXTENSION SET
    K820911 PBC NEEDLE BY NIPRO MED. INDUSTRIES
    K813649 PBC NEEDLE
    K813646 JMS DISPOSABLE SYRINGE
    K813648 JMS NEEDLE & MAC JECT
    K813647 PBC SYRINGE
    Search all 11 clearances from Philadelphia Biologics Center →