BTC · Class I · 21 CFR 868.5320

FDA Product Code BTC: Bag, Reservoir

Leading manufacturers include Pedia, LLC, Mem Medical, Inc. and Life Design Systems, Inc..

19
Total
19
Cleared
43d
Avg days
1979
Since

FDA 510(k) Cleared Bag, Reservoir Devices (Product Code BTC)

19 devices
1–19 of 19
Cleared Sep 25, 2018
PeDIA
K181424
Pedia, LLC
Anesthesiology · 117d
Cleared Jul 16, 1993
BREATHING BAGS
K932584
Merit Medical Systems, Inc.
Anesthesiology · 50d
Cleared Aug 16, 1982
ANESTHESIA BREATHING BAG, VARIOUS SIZES
K822116
Life Design Systems, Inc.
Anesthesiology · 28d
Cleared Aug 16, 1982
VOLUMETRIC CONTROLLER
K822216
Quest Medical, Inc.
Anesthesiology · 21d
Cleared Oct 09, 1979
THREE LITER BAG #M-512
K791910
Mem Medical, Inc.
Anesthesiology · 14d

About Product Code BTC - Regulatory Context