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

    LP-60 LOW PRESSURE INFLATION DEVICE

    K Number: K910205 · Decision Feb 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    14
    Review Days
    40

    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
    LP-60 LOW PRESSURE INFLATION DEVICE
    K Number
    K910205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Devices For Vascular Intervention, Inc.
    Date Received
    January 16, 1991
    Decision Date
    February 25, 1991
    Product Code
    MAV
    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
    MAV Syringe, Balloon Inflation

    Similar 510(k) Clearances

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

    Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fluent inflation device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    basixTOUCH40 Inflation Syringe

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fluent Inflation Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MASTRO PLUS BALLOON IN-DEFLATION DEVICE

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

    Other Clearances by Devices For Vascular Intervention, Inc.

    K Number Device Name
    K935929 MICROTRACK
    K920707 HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
    K914422 DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE
    K911678 ROTATING HEMOSTATIC VALVE
    K901601 HOLLOW MOTOR DRIVE UNIT
    K883933 INTRODUCING CATHETER
    K883981 GUIDING CATHETER (TIP SOFTNESS CHANGE)
    K883916 ROTATING HEMOSTATIC VALVE
    K883346 SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F
    K881088 ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
    Search all 14 clearances from Devices For Vascular Intervention, Inc. →