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

    AORTIC AND FEMORAL PERFUSION CANNULAE

    K Number: K801398 · Decision Jun 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    393
    Applicant Total
    30
    Review Days
    17

    Basic Information

    Device Name
    AORTIC AND FEMORAL PERFUSION CANNULAE
    K Number
    K801398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    TEXAS MEDICAL PRODUCTS, INC.
    Date Received
    June 13, 1980
    Decision Date
    June 30, 1980
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    RAP Femoral Venous Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);

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

    Other Clearances by TEXAS MEDICAL PRODUCTS, INC.

    K Number Device Name
    K893417 SURGIFRESH SUB-MICRON MASK NO. 901008-000
    K870932 SURGIFRESH SURGICAL SMOKE REMOVAL
    K851575 DR. BRUNO LNAGE MINI PHOTOMETER
    K830634 CARDIOTOMY FILTER
    K813587 DISPOSABLE THORACIC CATHETER
    K810532 DISPOSABLE STOPCOCK
    K810515 DISPOSABLE 2-STAGE CANNULA
    K810395 PRE-BYPASS FILTER
    K802544 DISPOSABLE QUICK RELEASE PERFUSION ADAP
    K802541 DISPOSABLE PARALLEL Y CONNECTORS
    Search all 30 clearances from TEXAS MEDICAL PRODUCTS, INC. →