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

    WavelinQ Plus EndoAVF System

    K Number: K192239 · Decision Oct 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    645
    Review Days
    59

    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
    WavelinQ Plus EndoAVF System
    K Number
    K192239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1252
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    August 19, 2019
    Decision Date
    October 17, 2019
    Product Code
    PQK
    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
    PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

    Similar 510(k) Clearances

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

    Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WavelinQ 4F EndoAVF System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ellipsys Vascular Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    everlinQ endoAVF System

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

    Other Clearances by C.R. Bard, Inc.

    K Number Device Name
    K254076 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
    K252971 Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    K251864 Rubber Utility Catheter
    K251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    K241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    K230356 Aspirex™ Thrombectomy System
    K223177 Highlander™ 014 PTA Balloon Dilatation Catheter
    K222793 WavelinQ™ Generator
    K220270 Aspirex Thrombectomy System
    K213203 Provena(TM) Midline Catheter
    Search all 645 clearances from C.R. Bard, Inc. →