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

    PINNACLE PRECISION ACCESS SYSTEM

    K Number: K111606 · Decision Oct 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    143
    Review Days
    116

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    Basic Information

    Device Name
    PINNACLE PRECISION ACCESS SYSTEM
    K Number
    K111606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Medical Corp.
    Date Received
    June 9, 2011
    Decision Date
    October 3, 2011
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by Terumo Medical Corp.

    K Number Device Name
    K111556 GLIDECROSS SUPPORT CATHETER
    K110540 TERUMO SUPPORT CATHETER
    K102008 GLIDESHEATH
    K091329 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
    K082997 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
    K090040 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
    K082847 PINNACLE ROII INTRODUCER SHEATH
    K082519 FINECROSS MG CORONARY MICRO-GUIDE CATHETER
    K082736 RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
    K082644 GLIDESHEATH
    Search all 143 clearances from Terumo Medical Corp. →