BLOOD HAND PUMP ADMINISTRATION SET— 510(k) K050115

Name: FDA 510(k) clearance K050115
Creator: U.S. Food and Drug Administration
Published: 2005-04-01

Substantially Equivalent

Cardinal Health, Alaris Products

FDA 510(k) clearance K050115 for BLOOD HAND PUMP ADMINISTRATION SET, Substantially Equivalent on 2005-04-01. Applicant: Cardinal Health, Alaris Products. Device class: 2.

Clearance details

Applicant: Cardinal Health, Alaris Products
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2005-01-18
Decision date: 2005-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.