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

    DYNABITE CARDIOVASCULAR BIOPSY FORCEPS

    K Number: K951447 · Decision Jul 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    120

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    Basic Information

    Device Name
    DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
    K Number
    K951447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4075
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portlyn Corp.
    Date Received
    March 29, 1995
    Decision Date
    July 27, 1995
    Product Code
    DWZ
    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
    DWZ Device, Biopsy, Endomyocardial

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    Other Clearances by Portlyn Corp.

    K Number Device Name
    K970083 DYNABITE HOT GI BIOPSY FORCEPS
    K952391 DYNABITE UROLOGICAL FORCEPS
    K944245 DYNABITE LAPAROSCOPIC FORCEPS
    K934506 DYNABITE HYSTEROSCOPIC FORCEPS
    K901300 BIOPSY FORCEPS
    K896147 BIOPSY FORCEP (NON-ELECTRIC)
    K896146 BIOPSY FORCEPS, (NON-RIGID)