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

    HEIMLICH MICRO TRACH

    K Number: K895130 · Decision Nov 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    26
    Review Days
    82

    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
    HEIMLICH MICRO TRACH
    K Number
    K895130
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Ballard Medical Products
    Date Received
    August 17, 1989
    Decision Date
    November 7, 1989
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

    Similar 510(k) Clearances

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

    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pilling Tracheostomy Tubes

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

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

    Other Clearances by Ballard Medical Products

    K Number Device Name
    K030721 QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
    K022398 REUSABLE BRONCHIAL BIOPSY FORCEPS
    K013892 LUTZ NEEDLE
    K000495 BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
    K993138 BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
    K990376 BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
    K982894 MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
    K974630 72 HOUR USE TRACH CARE WITH MICROBAN
    K964369 TRACH CARE SET WITH MICROBAN
    K951533 EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
    Search all 26 clearances from Ballard Medical Products →