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

    MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB

    K Number: K870073 · Decision Feb 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    10
    Review Days
    43

    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
    MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
    K Number
    K870073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Clinical Connections, Inc.
    Date Received
    January 8, 1987
    Decision Date
    February 20, 1987
    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 Clinical Connections, Inc.

    K Number Device Name
    K884435 RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
    K871540 SWIVEL CONNECTORS #014452/#014453/#014459-120
    K870325 #014160-TAB TUBING ROTATOR ADAPTOR
    K870477 DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 Y
    K870913 INJECTION SITE #014456-120
    K870912 T-CONNECTORS 014500/014501/014502/014503-120
    K870324 #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
    K870394 HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
    K870326 VARIOUS LUER AND TUBING FITTINGS