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

    SILCLAMPS DEGANIA SILICONE

    K Number: K920501 · Decision Jun 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    24
    Review Days
    119

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    Basic Information

    Device Name
    SILCLAMPS DEGANIA SILICONE
    K Number
    K920501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puritas Health Care, Inc.
    Date Received
    February 4, 1992
    Decision Date
    June 2, 1992
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Puritas Health Care, Inc.

    K Number Device Name
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    K935531 OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
    K940074 Y-TYPE BLOOD ADMINISTRATION SET
    K940055 MULTISET
    K940054 MEASURED VOLUME SOLUTION ADMINISTRATION SET
    K935583 SUCTION SET, TRACHAEL
    K940056 WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
    K935532 TRANSFER SET
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