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

    ProtekDuo Veno-Venous Cannula Sets

    K Number: K232480 · Decision Oct 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    21
    Review Days
    51

    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
    ProtekDuo Veno-Venous Cannula Sets
    K Number
    K232480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiacassist, Inc.
    Date Received
    August 16, 2023
    Decision Date
    October 6, 2023
    Product Code
    PZS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZS Dual Lumen Ecmo Cannula

    Similar 510(k) Clearances

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

    MC3 Crescent Jugular Dual Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MC3 Jugular Dual Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MC3 QuickFlow Dual Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cardiacassist, Inc.

    K Number Device Name
    K233736 LifeSPARC System
    K232132 LifeSPARC System
    K211830 LifeSPARC System
    K202751 TandemHeart Pump and Escort Controller
    K183623 LifeSPARC Pump, LifeSPARC Controller
    K181150 ProtekDuo Mini Veno-Venous Cannula Set
    K162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
    K162214 Protek Solo 24 Fr Venous Cannula Set
    K160257 PROTEK Duo 31 Fr. Veno-Venous Cannula Set
    K153295 TandemLung Oxygenator
    Search all 21 clearances from Cardiacassist, Inc. →