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

    AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE

    K Number: K071365 · Decision Nov 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    645
    Review Days
    175

    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
    AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
    K Number
    K071365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    May 15, 2007
    Decision Date
    November 6, 2007
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

    Similar 510(k) Clearances

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

    Spiro-VISTA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AeroJet Ventilation Catheter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

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

    Other Clearances by C.R. Bard, Inc.

    K Number Device Name
    K254076 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
    K252971 Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    K251864 Rubber Utility Catheter
    K251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    K241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    K230356 Aspirex™ Thrombectomy System
    K223177 Highlander™ 014 PTA Balloon Dilatation Catheter
    K222793 WavelinQ™ Generator
    K220270 Aspirex Thrombectomy System
    K213203 Provena(TM) Midline Catheter
    Search all 645 clearances from C.R. Bard, Inc. →