FDA Product Code BRZ: Set, Blood Transfusion
Leading manufacturers include Baxter Healthcare Corporation, Vygon Corp. and Churchill Corp..
30
Total
30
Cleared
102d
Avg days
1982
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Set, Blood Transfusion Devices (Product Code BRZ)
30 devices
Cleared
Nov 17, 2022
Blood Administration Sets
Baxter Healthcare Corporation
General Hospital
262d
Cleared
Jun 10, 2021
Blood Administration Set
Baxter Healthcare Corporation
General Hospital
125d
Cleared
Nov 17, 1999
MODIFIED BLOOD RECIPIENT SET
Baxter Healthcare Corp
General Hospital
58d
Cleared
Jul 27, 1987
IV ADMINISTRATION SET
Travenol Laboratories, S.A.
General Hospital
73d
Cleared
Jan 20, 1987
CHURCHILL BLOOD ADMINISTRATION SET
Churchill Corp.
General Hospital
69d
Cleared
May 03, 1985
VYGON EXCHANGE TRANSFUSION TRAY 275.00
Vygon Corp.
General Hospital
18d
About Product Code BRZ - Regulatory Context
510(k) Submission Activity
30 total 510(k) submissions under product code BRZ since 1982, with 30 receiving FDA clearance (average review time: 102 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.