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

    IBC VRV, MODEL 1350

    K Number: K992657 · Decision Feb 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    11
    Review Days
    193

    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
    IBC VRV, MODEL 1350
    K Number
    K992657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4430
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biophysics Corp.
    Date Received
    August 9, 1999
    Decision Date
    February 18, 2000
    Product Code
    DWD
    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
    DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    NIKKISO NK PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDISEAL SUCTION CANISTER

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

    Other Clearances by International Biophysics Corp.

    K Number Device Name
    K072688 LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
    K030181 INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
    K992785 IBC FLOGUARD, MODEL 6050
    K992964 IBC VENT VALVE, MODEL 1400
    K983272 IBC FLOPUMP, MODEL 6000
    K963703 ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
    K963756 IBC CARDIAC SUCTION WARD
    K963698 CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
    K955380 IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
    K955379 IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
    Search all 11 clearances from International Biophysics Corp. →