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

    WEDGE PRESSURE CATHETER

    K Number: K830604 · Decision Jul 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    6
    Review Days
    143

    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
    WEDGE PRESSURE CATHETER
    K Number
    K830604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Plasmedics, Inc.
    Date Received
    February 25, 1983
    Decision Date
    July 18, 1983
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

    Similar 510(k) Clearances

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

    HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swan-Ganz catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swang-Ganz IQ pulmonary artery catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swan-Ganz Catheters

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

    Other Clearances by Plasmedics, Inc.

    K Number Device Name
    K853559 STERILE BIOPSY NEEDLES
    K850263 PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
    K831601 APNEA ALARM FOR ADULT-PEDIATRIC & NEON
    K831650 ANESTHESIA/RESPIRATORY DISCONNECT -
    K823351 CENTRAL VENOUS CATHETER