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

    PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE

    K Number: K890292 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    10
    Review Days
    154

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    Basic Information

    Device Name
    PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
    K Number
    K890292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Coeur Laboratories, Inc.
    Date Received
    January 19, 1989
    Decision Date
    June 22, 1989
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Coeur Laboratories, Inc.

    K Number Device Name
    K971712 COEUR 130 ML ANGIOGRAPHIC SYRINGE
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    K960965 FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
    K885138 CAPILLARY TUBE, BLOOD COLLECTION
    K885202 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR
    K881646 UROLOGICAL CATHETER
    K874579 COEUR CONTROL SYRINGE
    K873597 TUBING, POLYETHYLENE
    K823920 COEURLOCK STERILE DISPOS. ANGIOGRAPHIC