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

    CRYOCARE CARDIAC SURGICAL SYSTEM

    K Number: K011040 · Decision Jun 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    22
    Review Days
    71

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    Basic Information

    Device Name
    CRYOCARE CARDIAC SURGICAL SYSTEM
    K Number
    K011040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endocare, Inc.
    Date Received
    April 5, 2001
    Decision Date
    June 15, 2001
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    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
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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    Other Clearances by Endocare, Inc.

    K Number Device Name
    K101333 CRYOCARE CS SURGICAL SYSTEM
    K062175 CRYOCARE CN2 SYSTEM
    K060279 CRYOCARE CS SURGICAL SYSTEM
    K050347 MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
    K032333 CRYOCARE CS SURGICAL SYSTEM
    K023757 CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
    K021010 MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
    K020082 ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM
    K011074 CRYOCARE SURGICAL SYSTEM
    K003811 CRYOCARE SURGICAL SYSTEM
    Search all 22 clearances from Endocare, Inc. →