BSK · Class II · 21 CFR 868.5750

FDA Product Code BSK: Cuff, Tracheal Tube, Inflatable

Leading manufacturers include Hospitech Respiration , Ltd., Instrumentation Industries, Inc. and Aw Technologies Aps.

40
Total
40
Cleared
164d
Avg days
1979
Since
40 devices
25–40 of 40
Cleared Dec 17, 1997
PILOT TUBE REPAIR KIT
K973755
Instrumentation Industries, Inc.
Anesthesiology · 76d
Cleared Apr 06, 1995
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046
Rusch Intl.
Anesthesiology · 31d
Cleared Nov 23, 1988
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638
Instrumentation Industries, Inc.
Anesthesiology · 16d
Cleared Apr 14, 1988
CUFFCHECK
K881178
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 27d
Cleared Nov 28, 1983
RESPIRONICS PR VALVE
K833327
Respironics, Inc.
Anesthesiology · 62d
Cleared Nov 27, 1979
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265
Shiley, Inc.
Anesthesiology · 18d