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
25–48 of 128
Cleared Apr 23, 1990
SHILEY PHONATION VALVE
K900548
Shiley, Inc.
Anesthesiology · 77d
Cleared Feb 22, 1990
TRACHEOSTOMY TRAY
K896798
Westmark, Sterile Packing Systems, Inc. (Sps)
Anesthesiology · 83d
Cleared Nov 07, 1989
HEIMLICH MICRO TRACH
K895130
Ballard Medical Products
Anesthesiology · 82d
Cleared Aug 07, 1989
HOOD PEDIATRIC TRACHEOSTOMY TUBE
K893866
Hood Laboratories
Anesthesiology · 73d
Cleared Jan 17, 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730
Shiley, Inc.
Anesthesiology · 68d
Cleared Nov 02, 1988
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
K884427
Bivona Medical Technologies
Anesthesiology · 13d
Cleared Jun 28, 1988
HOOD TRACHEAL STOMA BUTTON
K882430
Hood Laboratories
Anesthesiology · 14d
Cleared Mar 09, 1988
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614
Shiley, Inc.
Anesthesiology · 22d
Cleared Feb 29, 1988
PREFILLED WATER FOR IRRIGATION USP
K880316
Automatic Liquid Packaging, Inc.
Anesthesiology · 34d
Cleared Feb 29, 1988
PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
K880317
Automatic Liquid Packaging, Inc.
Anesthesiology · 34d
Cleared Feb 12, 1988
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247
Shiley, Inc.
Anesthesiology · 23d
Cleared May 14, 1987
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181
Cook, Inc.
Anesthesiology · 119d
Cleared Jan 15, 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061
Shiley, Inc.
Anesthesiology · 22d
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 Mar 04, 1986
TRACHEOSTOMY CARE KIT
K855130
Dynarex Corp.
Anesthesiology · 71d
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 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 Mar 15, 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832
Shiley, Inc.
Anesthesiology · 129d