BTC · Class I · 21 CFR 868.5320

FDA Product Code BTC: Bag, Reservoir

Leading manufacturers include Pedia, LLC and Merit Medical 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

About Product Code BTC - Regulatory Context