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 Trinity Laboratories, Inc..

128
Total
128
Cleared
107d
Avg days
1976
Since
128 devices
25–48 of 128
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 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 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 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 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