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

    HEARTPORT MAZE SYSTEM: CRYOPROBE SET

    K Number: K970496 · Decision May 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    24
    Review Days
    88

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    Basic Information

    Device Name
    HEARTPORT MAZE SYSTEM: CRYOPROBE SET
    K Number
    K970496
    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
    Heartport, Inc.
    Date Received
    February 10, 1997
    Decision Date
    May 9, 1997
    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 Heartport, Inc.

    K Number Device Name
    K994243 DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
    K981995 QUICKDRAW VENOUS CANNULA
    K990772 DIRECTFLOW ARTERIAL CANNULA
    K981009 HEARTPORT ENDOPULMONARY VENT CATHETER
    K974736 HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
    K974175 HEARTPORT ENDOAORTIC CLAMP CATHETER
    K972570 HEARTPORT INTRODUCER SHEATH
    K971291 HEARTPORT ENDOARTERIAL RETURN CANNULA
    K964302 HEARTPORT THORACIC TROCAR
    K964161 HEARTPORT ENDOAORTIC CLAMP
    Search all 24 clearances from Heartport, Inc. →