BARD PARKER 150CC BELLOWS RESERVOIR— 510(k) K854424

Name: FDA 510(k) clearance K854424
Creator: U.S. Food and Drug Administration
Published: 1985-11-20

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K854424 for BARD PARKER 150CC BELLOWS RESERVOIR, Substantially Equivalent on 1985-11-20. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1985-11-05
Decision date: 1985-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.