BTS · Class II · 21 CFR 868.5720

FDA Product Code BTS: Tube, Bronchial (w/wo Connector)

Leading manufacturers include Portex, Inc., Concord/Portex and Rusch Intl..

6
Total
6
Cleared
70d
Avg days
1977
Since

FDA 510(k) Cleared Tube, Bronchial (w/wo Connector) Devices (Product Code BTS)

6 devices
1–6 of 6
Cleared Nov 27, 1995
RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
K953963
Rusch, Inc.
Anesthesiology · 97d
Cleared Jun 08, 1995
RUSCH ENDOBRONCHIAL TUBE SETS
K951091
Rusch Intl.
Anesthesiology · 91d
Cleared Aug 03, 1990
MODIFIED ENDOBRONCHIAL TUBE
K902116
Concord/Portex
Anesthesiology · 85d
Cleared Jan 17, 1984
ENDOBRONCHIAL TWIN LUMEN TUBE
K834565
Portex, Inc.
Anesthesiology · 20d
Cleared Dec 27, 1983
BRONCHOSCOPY TUBE W/ULTRA LOCUFF
K833297
Surgitek
Anesthesiology · 95d
Cleared Aug 04, 1977
BRONCHO-CATH
K771219
Mallinckrodt Critical Care
Anesthesiology · 30d

About Product Code BTS - Regulatory Context