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
97–120 of 129
Cleared Jun 14, 1984
MONTGOMERY TRACHEAL T-TUBE
K841266
E. Benson Hood Laboratories, Inc.
Anesthesiology · 80d
Cleared May 02, 1984
PEDIA-TRAKE CRICOTHYROTOMY KIT
K840925
Intl. Medical Devices , Ltd.
Anesthesiology · 61d
Cleared Apr 30, 1984
COMMUNI-TRACH TUBE
K841546
Implant Technology, Inc.
Anesthesiology · 14d
Cleared Mar 15, 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832
Shiley, Inc.
Anesthesiology · 129d
Cleared Mar 09, 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539
Shiley, Inc.
Anesthesiology · 30d
Cleared Jan 27, 1984
H.R. JAKOBI SURG. INSTRUMENTS #9 48
K834179
Imm Enterprises , Ltd.
Anesthesiology · 67d
Cleared Oct 14, 1983
PERCUTANEOUS TRACHEOSTOMY DEVICE
K832498
Frederic J. Toye, M.D.
Anesthesiology · 79d
Cleared Jul 07, 1983
TRACHEOSTOMY TUBE
K831511
Implant Technology, Inc.
Anesthesiology · 56d
Cleared Jul 07, 1983
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720
Sherwood Medical Co.
Anesthesiology · 37d
Cleared Mar 29, 1983
EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-
K830509
Frederic J. Toye, M.D.
Anesthesiology · 40d
Cleared Jan 08, 1983
COMMUNITRACH TUBE
K823291
Implant Technology, Inc.
Anesthesiology · 64d
Cleared Oct 27, 1982
CONTAINERS OF STERILE WATER OS SALINE
K822811
American Pharmaseal Div. Ahsc
Anesthesiology · 37d
Cleared Aug 20, 1982
SURGI TEK'S DISPOS. INNER CANNULA FOR
K822295
Medical Engineering Corp.
Anesthesiology · 18d
Cleared Feb 23, 1982
TRACH TAPE
K820099
Stan-Pak Ent.
Anesthesiology · 41d
Cleared Jun 26, 1981
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447
Shiley, Inc.
Anesthesiology · 35d
Cleared May 13, 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033
Shiley, Inc.
Anesthesiology · 28d
Cleared May 05, 1981
MONTGOMERY SILICONE TRACHEAL T-TUBE
K810978
Boston Medical Products, Inc.
Anesthesiology · 25d
Cleared Mar 17, 1981
MARTIN TRACH-SECURE
K810575
Diatek, Inc.
Anesthesiology · 14d
Cleared Mar 04, 1981
REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
K810321
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 26d
Cleared Mar 04, 1981
TRACHEOSTOMA VENT
K810436
Bivona Medical Technologies
Anesthesiology · 13d
Cleared Feb 02, 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106
Shiley, Inc.
Anesthesiology · 17d
Cleared Dec 19, 1980
MONTG. TRACHEAL CANNULA
K802916
Boston Medical Products, Inc.
Anesthesiology · 30d
Cleared Sep 09, 1980
CUFFED TRACHEA TUBE FOR USE W/PERTRACH
K801379
Frederic J. Toye, M.D.
Anesthesiology · 90d
Cleared Aug 27, 1980
MARTIN TRACH-SECURE
K801931
Acucare Medical, Inc.
Anesthesiology · 15d