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 American Healthcare Corp..

129
Total
129
Cleared
109d
Avg days
1976
Since
129 devices
49–72 of 129
Cleared May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K901079
L H M Ent., Inc.
Anesthesiology · 72d
Cleared Apr 23, 1990
SHILEY PHONATION VALVE
K900548
Shiley, Inc.
Anesthesiology · 77d
Cleared Mar 16, 1990
STAT-TRACH(TM) VENTILATION CATHETER
K894096
Statron Corp.
Anesthesiology · 280d
Cleared Feb 22, 1990
TRACHEOSTOMY TRAY
K896798
Westmark, Sterile Packing Systems, Inc. (Sps)
Anesthesiology · 83d
Cleared Jan 09, 1990
TRAUMAFUSE TRACH SHIELD
K895162
The Traumafuse Co.
Anesthesiology · 140d
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 May 25, 1989
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
K885139
Pertrach
Anesthesiology · 161d
Cleared Apr 27, 1989
AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
K890342
Eastmed Enterprises, Inc.
Anesthesiology · 94d
Cleared Jan 17, 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730
Shiley, Inc.
Anesthesiology · 68d
Cleared Nov 03, 1988
PREMIER DECANNULATION STOPPER
K884015
Premier Dental
Anesthesiology · 42d
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
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
K874450
Surgitech C/O Collier, Shannon, Rill & Scott
Anesthesiology · 123d
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 Dec 31, 1987
QUICKTRACH
K874742
Posey Co.
Anesthesiology · 43d
Cleared Nov 24, 1987
TODD MEDICAL/SKILLED CARE PRODUCTS
K873499
Todd Medical, Inc.
Anesthesiology · 85d
Cleared Sep 16, 1987
LARKEL DEVICE W/ATTACHMENTS A-H
K872486
Seidel Medizin GmbH
Anesthesiology · 85d
Cleared Jun 08, 1987
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
K871199
Frederic J. Toye, M.D.
Anesthesiology · 75d
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