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

    INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES

    K Number: K131446 · Decision Oct 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    65
    Review Days
    161

    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
    INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
    K Number
    K131446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra LifeSciences Corporation
    Date Received
    May 20, 2013
    Decision Date
    October 28, 2013
    Product Code
    DQR
    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
    DQR Cannula, Catheter

    Similar 510(k) Clearances

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

    18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANGIODYNAMICS, INC., MICRO ACCESS KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RMI INTERNAL MAMMARY ARTERY CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED SHILEY FEMORAL VENOUS CANNULA

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

    Other Clearances by Integra LifeSciences Corporation

    K Number Device Name
    K251162 CUSA® Clarity Ultrasonic Surgical Aspirator System
    K250752 AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
    K240493 CUSA® Clarity Ultrasonic Surgical Aspirator System
    K230427 CUSA Clarity Ultrasonic Surgical Aspirator System
    K221835 CUSA Clarity Ultrasonic Surgical Aspirator System
    K221763 CUSA Clarity Ultrasonic Surgical Aspirator System
    K210128 INTEGRA Wound Matrix (Macro-Channels)
    K210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
    K193346 Codman Surgical Patties & Strips
    K201507 Cadence Total Ankle System
    Search all 65 clearances from Integra LifeSciences Corporation →