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

    INTHERM RADIALLY EXPANDING DILATING INTRODUCER

    K Number: K931489 · Decision Oct 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    6
    Review Days
    204

    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
    INTHERM RADIALLY EXPANDING DILATING INTRODUCER
    K Number
    K931489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innerdyne Medical, Inc.
    Date Received
    March 25, 1993
    Decision Date
    October 15, 1993
    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 Innerdyne Medical, Inc.

    K Number Device Name
    K943253 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
    K943056 SINGLE STICK RADIALLY EXPANDING DILATOR
    K940428 INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
    K940232 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
    K932692 INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT