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

    MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS

    K Number: K801828 · Decision Aug 27, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    55
    Review Days
    27

    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
    MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
    K Number
    K801828
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Graphic Controls Corp.
    Date Received
    July 31, 1980
    Decision Date
    August 27, 1980
    Product Code
    DTL
    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
    DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Attachable Cath Lab Hemostasis Valve

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Passage Hemostasis Valve

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROTATING ADAPTERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLIGN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE

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

    Other Clearances by Graphic Controls Corp.

    K Number Device Name
    K981964 MEDI-TRACE 4103 NEONATAL ELECTRODE
    K983287 MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
    K974730 SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
    K980857 MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
    K972970 MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
    K964387 POINT OF USE II SHARPS-A-GATOR
    K964279 SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
    K963151 MEDI-TRACE 5700 RESTING ECG ELECTRODE
    K963038 MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
    K960968 MEDI-TRACE 200, MEDI-TRACE 200-30
    Search all 55 clearances from Graphic Controls Corp. →