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

    ViewFlex™ Eco Reprocessed ICE Catheter

    K Number: K231588 · Decision Jun 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    57
    Review Days
    29

    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
    ViewFlex™ Eco Reprocessed ICE Catheter
    K Number
    K231588
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ABBOTT MEDICAL
    Date Received
    June 1, 2023
    Decision Date
    June 30, 2023
    Product Code
    OWQ
    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
    OWQ Reprocessed Intravascular Ultrasound Catheter

    Similar 510(k) Clearances

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

    Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

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

    Other Clearances by ABBOTT MEDICAL

    K Number Device Name
    K253459 OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
    K260212 EnSite™ X EP System
    K253907 Disposable Radiofrequency Cannula
    K260499 Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
    K252512 Armada™ 14 NC PTA Catheter
    K253516 Assert-IQ (DM5100)
    K252417 Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
    K253232 Seguin Annuloplasty Ring
    K250031 Amplatzer Guidewire
    K252013 EnSite™ X EP System
    Search all 57 clearances from ABBOTT MEDICAL →