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

    PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM

    K Number: K903699 · Decision Sep 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    2
    Review Days
    20

    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
    PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
    K Number
    K903699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Passy & Passy, Inc.
    Date Received
    August 15, 1990
    Decision Date
    September 4, 1990
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

    Similar 510(k) Clearances

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

    Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRACOE vario

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley Neonatal/Pediatric Tracheostomy Tube

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

    Other Clearances by Passy & Passy, Inc.

    K Number Device Name
    K851016 PASSY-MUIR TRACH VALVE