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
25–48 of 129
Cleared Aug 27, 1996
CPR TRACHEOTOMY CARE TRAY
K960205
Custom Pack Reliability
Anesthesiology · 224d
Cleared Aug 15, 1996
MOORE TRACHEOSTOMY TUBE
K962240
Boston Medical Products, Inc.
Anesthesiology · 65d
Cleared May 16, 1996
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
K953559
Seidel Medizin GmbH
Anesthesiology · 331d
Cleared Aug 09, 1995
TRACHEOSTOMY CARE KIT
K952416
Medi-Flex Hospital Products, Inc.
Anesthesiology · 78d
Cleared Feb 27, 1995
SSV PHONATE(TM) SHILEY SPEAKING VALVE
K945406
Mallinckrodt Medical Tpi, Inc.
Anesthesiology · 116d
Cleared Feb 27, 1995
SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
K945407
Mallinckrodt Medical Tpi, Inc.
Anesthesiology · 116d
Cleared Feb 14, 1995
TRACHEOSTOMY CARE KIT
K941470
Clinical Resources, Inc.
Anesthesiology · 323d
Cleared Jun 16, 1993
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
K924193
American Healthcare Corp.
Anesthesiology · 300d
Cleared Apr 02, 1993
TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
K924191
American Healthcare Corp.
Anesthesiology · 225d
Cleared Jan 06, 1993
TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
K924194
American Healthcare Corp.
Anesthesiology · 139d
Cleared Jan 06, 1993
TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
K924195
American Healthcare Corp.
Anesthesiology · 139d
Cleared Dec 10, 1992
TRACHEOSTOMY CARE SET WITH GLOVES
K923834
American Healthcare Corp.
Anesthesiology · 132d
Cleared Dec 03, 1992
CMI STOMA COVERS
K925249
Community Medical Center
Anesthesiology · 48d
Cleared Sep 02, 1992
LOW PROFILE TRACHEOSTOMY TUBE
K922749
Concord/Portex
Anesthesiology · 86d
Cleared Aug 27, 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281
Trinity Laboratories, Inc.
Anesthesiology · 218d
Cleared Aug 27, 1992
TRACHEOSTOMY CARE KIT
K921281
Trinity Laboratories, Inc.
Anesthesiology · 163d
Cleared Jul 27, 1992
BIVONA TRACHEAL T-TUBE STENT
K920604
Bivona Medical Technologies
Anesthesiology · 167d
Cleared Jul 10, 1992
EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
K914743
Pertrach
Anesthesiology · 273d
Cleared Aug 16, 1991
TRACHEOSTOMY TUBE AND CUFF
K912124
Concord/Portex
Anesthesiology · 95d
Cleared Jun 19, 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469
Bivona Medical Technologies
Anesthesiology · 15d
Cleared Sep 25, 1990
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K903730
Concord/Portex
Anesthesiology · 40d
Cleared Aug 17, 1990
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
K901920
Primecare, Inc.
Anesthesiology · 109d
Cleared Aug 10, 1990
MODIFIED SCOOP TRANSTRACHEAL CATHETERS
K902281
Transtracheal Systems
Anesthesiology · 80d
Cleared May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K901078
L H M Ent., Inc.
Anesthesiology · 72d