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

    STOPCOCK INTRAVENOUS THERAPY

    K Number: K940070 · Decision Apr 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    24
    Review Days
    88

    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
    STOPCOCK INTRAVENOUS THERAPY
    K Number
    K940070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritas Health Care, Inc.
    Date Received
    January 6, 1994
    Decision Date
    April 4, 1994
    Product Code
    FMG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMG Stopcock, I.V. Set

    Similar 510(k) Clearances

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

    Qitexio® 4-Way Stopcock (QIT014)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Three Way Stop Cock

    FDA 510(k)
    FDA Class 2 ·General Hospital

    lntravascular Administration Sets with Stopcock and Manifold

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SafePort(TM) Manifold (or Stopcock)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Clicky Cross

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Puritas Health Care, Inc.

    K Number Device Name
    K942339 SKIN NEUVEAU SCAR TREATMENT
    K941197 SILK*SKIN SCAR TREATMENT
    K935600 TRACHEAL SUCTION CATHETER
    K935531 OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
    K940074 Y-TYPE BLOOD ADMINISTRATION SET
    K940055 MULTISET
    K940054 MEASURED VOLUME SOLUTION ADMINISTRATION SET
    K935583 SUCTION SET, TRACHAEL
    K940056 WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
    K935532 TRANSFER SET
    Search all 24 clearances from Puritas Health Care, Inc. →