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

    INTRODUCER, PERCUTANEOUS

    K Number: K870907 · Decision Apr 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    22
    Review Days
    35

    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
    INTRODUCER, PERCUTANEOUS
    K Number
    K870907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Med Fusion Systems, Inc.
    Date Received
    March 5, 1987
    Decision Date
    April 9, 1987
    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 Med Fusion Systems, Inc.

    K Number Device Name
    K873961 INFUMED 300 AMBULATORY INFUSION PUMP
    K870524 AMBULATORY INFUSION PUMP DRUG RESERVOIR
    K864407 REFILLABLE SYRINGE
    K863814 BAG SPIKE EXTENSION SET
    K860616 VOLUME CONTROL SET WITH EXTENSION
    K860803 IV FILTER EXTENSION SET
    K844313 INFUSET W/HUBER NEEDLE
    K842984 EXTENSION SET W/INJECTION SITE
    K842143 BENT WINGED MINI-VOL INFUSION SET
    K841882 THREE WAY INFUSION SET
    Search all 22 clearances from Med Fusion Systems, Inc. →