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

    BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55

    K Number: K130197 · Decision Feb 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    134
    Review Days
    30

    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
    BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
    K Number
    K130197
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    January 28, 2013
    Decision Date
    February 27, 2013
    Product Code
    ONB
    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
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

    Similar 510(k) Clearances

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

    ProSeal™ Transfer Injector (421120, 421130, 421140)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chemfort Female Luer Lock Adaptor

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZeroClear™ Bag Access (423100)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Becton, Dickinson and Company

    K Number Device Name
    K260128 BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
    K252506 BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder
    K252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
    K260184 Onclarity™ Self-Collection Kit
    K252040 BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
    K250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
    K250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
    K250059 BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
    K251713 BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
    K251350 BD Plastipak™ Syringe
    Search all 134 clearances from Becton, Dickinson and Company →