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

    AUTOMATIC PULL BACK DEVICE

    K Number: K933517 · Decision Oct 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    19
    Review Days
    87

    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
    AUTOMATIC PULL BACK DEVICE
    K Number
    K933517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Imaging Systems, Inc.
    Date Received
    July 20, 1993
    Decision Date
    October 15, 1993
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

    Similar 510(k) Clearances

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

    InQwire Amplatz Guide Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Enroute 0.014'' Transcarotid Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EmeryGlide™ (EG18008901)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

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

    Other Clearances by Cardiovascular Imaging Systems, Inc.

    K Number Device Name
    K970049 BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
    K942231 MICROVIEW II/MICRORAIL II CATHETERS
    K930232 CVIS INSIGHT IMAGING GUIDE CATHETER
    K924922 CVIS INSIGHT IMAGING CATHETER
    K930311 CVIS LONGVIEW
    K921879 CBIS CATHETER PULL-BACK DEVICE
    K921750 CVIS INSIGHT III SYSTEM
    K921631 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
    K921148 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
    K921147 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
    Search all 19 clearances from Cardiovascular Imaging Systems, Inc. →