DRAGON HEART PISTON SYRINGE— 510(k) K042547

Name: FDA 510(k) clearance K042547
Creator: U.S. Food and Drug Administration
Published: 2004-12-01

Substantially Equivalent

Dragon Heart Medical Devices Co., Ltd.

FDA 510(k) clearance K042547 for DRAGON HEART PISTON SYRINGE, Substantially Equivalent on 2004-12-01. Applicant: Dragon Heart Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dragon Heart Medical Devices Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2004-09-20
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Elmhurst, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.