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

    SCI MED PERICARDIAL SUBSTITUTE

    K Number: K791792 · Decision Dec 7, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    109
    Review Days
    85

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    Basic Information

    Device Name
    SCI MED PERICARDIAL SUBSTITUTE
    K Number
    K791792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scimed Life Systems, Inc.
    Date Received
    September 13, 1979
    Decision Date
    December 7, 1979
    Product Code
    DXZ
    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
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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    Other Clearances by Scimed Life Systems, Inc.

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    K980360 SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
    K974559 SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
    K974684 SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
    K973945 LUGE GUIDE WIRE
    K970823 SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
    K964551 CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID
    K970244 SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
    K965023 CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
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