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

    MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

    K Number: K043398 · Decision Mar 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    21
    Review Days
    81

    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
    MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
    K Number
    K043398
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neometrics, Inc.
    Date Received
    December 10, 2004
    Decision Date
    March 1, 2005
    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 Neometrics, Inc.

    K Number Device Name
    K152560 Bard Snare Retrieval Kit
    K150225 NovaGold High Performance Guidewire
    K143135 Spring Coil Guidewire
    K133076 NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
    K123439 NEO ERCP GUIDEWIRE
    K101729 NEOWIRE PTA/PTCA GUIDEWIRE
    K070150 VASCUPUNCTURE PICC GUIDEWIRE
    K040786 VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
    K033321 SELECTIVA SB GUIDEWIRE
    K031652 VASCUPUNCTURE PICC GUIDEWIRE
    Search all 21 clearances from Neometrics, Inc. →