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

    TVC Imaging System, TVC Catheter

    K Number: K163345 · Decision Jun 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    11
    Review Days
    204

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    Basic Information

    Device Name
    TVC Imaging System, TVC Catheter
    K Number
    K163345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infraredx, Inc.
    Date Received
    November 29, 2016
    Decision Date
    June 21, 2017
    Product Code
    OGZ
    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
    OGZ Catheter, Intravascular, Plaque Morphology Evaluation

    Similar 510(k) Clearances

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

    Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

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    FDA Class 2 ·Cardiovascular

    Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

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    TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

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    FDA Class 2 ·Cardiovascular

    TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

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    FDA Class 2 ·Cardiovascular

    TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

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    FDA Class 2 ·Cardiovascular

    TVC IMAGING SYSTEM MODEL NIRS-MC7-70

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

    Other Clearances by Infraredx, Inc.

    K Number Device Name
    K241576 Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
    K213303 Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
    K183599 Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
    K141682 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
    K133897 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
    K130719 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
    K123108 TVC IMAGING SYSTEM MODEL NIRS-MC7-70
    K093993 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
    K072932 INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
    K052908 INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
    Search all 11 clearances from Infraredx, Inc. →