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

    ANGEION HEMOSTASIS VALVE INTRODUCER

    K Number: K894446 · Decision Nov 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    7
    Review Days
    136

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ANGEION HEMOSTASIS VALVE INTRODUCER
    K Number
    K894446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Angeion Corp.
    Date Received
    July 17, 1989
    Decision Date
    November 30, 1989
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.

    FieldFlex Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Echo Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Introducer Sheath Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards eSheath+ introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aventus Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Protaryx Transseptal Puncture Device (PTX2-001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Angeion Corp.

    K Number Device Name
    K921757 ANGEION IGITAL ANGEFLATOR
    K925533 ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
    K915719 ANGEION ENDOSCOPIC VALVE SEAL
    K902377 ANGEFLATOR(TM)
    K895580 Y-ADAPTER W/THOUY BORST
    K871153 CATHETER INTRODUCER