BTO · Class II · 21 CFR 868.5800

FDA Product Code BTO: Tube, Tracheostomy (w/wo Connector)

Leading manufacturers include Shiley, Inc., Bivona Medical Technologies and Frederic J. Toye, M.D..

129
Total
129
Cleared
109d
Avg days
1976
Since
129 devices
73–96 of 129
Cleared Nov 03, 1986
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
K862436
Acutronic Medical Systems AG
Anesthesiology · 130d
Cleared Sep 09, 1986
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
K862909
Intl. Medical Devices , Ltd.
Anesthesiology · 40d
Cleared Aug 06, 1986
MINI-TRACH KIT
K862167
Portex, Inc.
Anesthesiology · 58d
Cleared Jun 18, 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267
Bivona Medical Technologies
Anesthesiology · 5d
Cleared May 09, 1986
MICRO-TRACHEOSTOMY CARE KIT
K861645
Aci Medical, Inc.
Anesthesiology · 9d
Cleared Apr 11, 1986
TRACHEAL TUBES
K853051
Erie Medical
Anesthesiology · 266d
Cleared Mar 04, 1986
TRACHEOSTOMY CARE KIT
K855130
Dynarex Corp.
Anesthesiology · 71d
Cleared Feb 03, 1986
TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
K854252
Transtracheal Systems
Anesthesiology · 104d
Cleared Jan 27, 1986
LARYNGECTOMY TUBE, CUFFED
K860176
Sheridan Catheter Corp.
Anesthesiology · 10d
Cleared Dec 19, 1985
THE HOOD LIFE SAVER
K853511
Hood Laboratories
Anesthesiology · 120d
Cleared Dec 06, 1985
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419
Hood Laboratories
Anesthesiology · 114d
Cleared Sep 05, 1985
LGT TUBE
K852413
Mallinckrodt Critical Care
Anesthesiology · 91d
Cleared Jul 08, 1985
BIVONA TRACHEOSTOMA VALVE II
K852272
Bivona Medical Technologies
Anesthesiology · 41d
Cleared Jun 07, 1985
PASSY-MUIR TRACH VALVE
K851016
Passy & Passy, Inc.
Anesthesiology · 87d
Cleared May 28, 1985
BFW VOICE GENERATOR
K851462
Bfw Laboratories, Inc.
Anesthesiology · 46d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE TRAY
K850445
Paco Research Corp.
Anesthesiology · 34d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE KIT
K850446
Paco Research Corp.
Anesthesiology · 34d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE KIT
K850456
Excel Health Care Products
Anesthesiology · 33d
Cleared Oct 23, 1984
WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
K843785
Intl. Medical Devices , Ltd.
Anesthesiology · 26d
Cleared Oct 19, 1984
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729
Shiley, Inc.
Anesthesiology · 25d
Cleared Oct 19, 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730
Shiley, Inc.
Anesthesiology · 25d
Cleared Oct 15, 1984
PERCUTANEOUS CRICOTHYROIDOTOMY
K822440
Frederic J. Toye, M.D.
Anesthesiology · 794d
Cleared Sep 19, 1984
TRACHEAL TUBE 16 GAUGE-1.65MM-
K832466
Erie Medical
Anesthesiology · 421d
Cleared Jul 06, 1984
ALL-HANDS TRACHEOSTOMY CARE SET 0101
K842415
All-Hands Medical Supply, Inc.
Anesthesiology · 16d