K210335

Substantially Equivalent

Blood Administration Set

Applicant: Baxter Healthcare Corporation
Product code: BRZ
Advisory panel: General Hospital
Date received: 2021-02-05
Decision date: 2021-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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