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 Hood Laboratories.

128
Total
128
Cleared
107d
Avg days
1976
Since
128 devices
49–72 of 128
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 Jul 07, 1983
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720
Sherwood Medical Co.
Anesthesiology · 37d
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 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 Oct 30, 1979
TRACHEOSTOMY CARE KIT
K792069
National Patent Development Corp.
Anesthesiology · 15d
Cleared Jun 22, 1979
TRACHE FITTING M-307
K790930
Mem Medical, Inc.
Anesthesiology · 38d
Cleared Jun 13, 1979
TRACHEOSTOMY TUBES, SHORT AND LONG TERM
K791044
Extracorporeal Medical Specialities, Inc.
Anesthesiology · 8d
Cleared Apr 03, 1979
TRACH CARE KIT
K790437
Abco Dealers, Inc.
Anesthesiology · 27d
Cleared Dec 20, 1977
ENDOTRACHEAL TUBE
K772138
Medline Industries, Inc.
Anesthesiology · 36d
Cleared Feb 09, 1977
SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE
K770218
Shiley, Inc.
Anesthesiology · 7d