IV ADMINISTRATION SET— 510(k) K871908

Name: FDA 510(k) clearance K871908
Creator: U.S. Food and Drug Administration
Published: 1987-07-27

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K871908 for IV ADMINISTRATION SET, Substantially Equivalent on 1987-07-27. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1987-05-15
Decision date: 1987-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, 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.