DeviceClearance

Product code BRZ— General Hospital

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

Classification name
Set, Blood Transfusion
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Total cleared
30
First cleared
Most recent

Market context for product code BRZ

FDA has cleared 30 devices under product code BRZ between 1982 and 2022, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code BRZ

Adverse events under product code BRZ

product code BRZ
Malfunction
458
Total
458

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code BRZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.