PLUME SAFETY AVF NEEDLE— 510(k) K040247

Substantially Equivalent

Jms North America Corp.

FDA 510(k) clearance K040247 for PLUME SAFETY AVF NEEDLE, Substantially Equivalent on 2004-03-03. Applicant: Jms North America Corp..

Clearance details

Applicant: Jms North America Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-03
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Hayward, CA, US

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Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.