LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202125
    Device Name
    Century Perfusion System
    Manufacturer
    Century HLM, LLC
    Date Cleared
    2021-03-07

    (219 days)

    Product Code
    DTQ, DTO
    Regulation Number
    870.4220
    Why did this record match?
    Applicant Name (Manufacturer) :

    Century HLM, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
    Device Description
    The Century Perfusion System is a modular system, like the Stöckert S5 System, consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces.
    Ask a Question

    Page 1 of 1