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

    ATLANTIS 018 PERIPHERAL IMAGING CATHETER

    K Number: K073623 · Decision Mar 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    432
    Review Days
    78

    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
    ATLANTIS 018 PERIPHERAL IMAGING CATHETER
    K Number
    K073623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    December 26, 2007
    Decision Date
    March 13, 2008
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

    Similar 510(k) Clearances

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

    ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mendaera Guidance System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro® 3S Needle Guide Kit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultrasound Transducer Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    UltraDrape UGPIV Barrier and Securement (34-15)

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

    Other Clearances by Boston Scientific Corp

    K Number Device Name
    K243245 IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
    K231328 LUX-Dx II (M302); LUX-Dx II+ (M312)
    K152853 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
    K150692 AXIOS Stent with Electrocautery Enhanced Delivery System
    K150303 XXL Vascular Balloon Dilatation Catheter
    K150186 Chariot Guiding Sheath
    K150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
    K141820 JAGWIRE HIGH PERFORMANCE GUIDWIRE
    K141344 EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
    K141335 EXPEL APD DRAINAGE CATHETER SYSTEM
    Search all 432 clearances from Boston Scientific Corp →