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

    COEUR CONTROL SYRINGE

    K Number: K874579 · Decision Jan 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    10
    Review Days
    74

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    Basic Information

    Device Name
    COEUR CONTROL SYRINGE
    K Number
    K874579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Coeur Laboratories, Inc.
    Date Received
    November 6, 1987
    Decision Date
    January 19, 1988
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Coeur Laboratories, Inc.

    K Number Device Name
    K971712 COEUR 130 ML ANGIOGRAPHIC SYRINGE
    K965214 COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
    K960965 FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
    K890292 PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
    K885138 CAPILLARY TUBE, BLOOD COLLECTION
    K885202 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR
    K881646 UROLOGICAL CATHETER
    K873597 TUBING, POLYETHYLENE
    K823920 COEURLOCK STERILE DISPOS. ANGIOGRAPHIC