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

    PeriCross™ Epicardial Access Kit

    K Number: K243954 · Decision Apr 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    682
    Applicant Total
    3
    Review Days
    122

    Basic Information

    Device Name
    PeriCross™ Epicardial Access Kit
    K Number
    K243954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CIRCA Scientific, Inc.
    Date Received
    December 23, 2024
    Decision Date
    April 24, 2025
    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 CIRCA Scientific, Inc.

    K Number Device Name
    K240004 CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer
    K222311 CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System