MODIFICATION TO JMS A.V. FISTULA NEEDLE SET— 510(k) K000845

Substantially Equivalent

Jms Co., Ltd.

FDA 510(k) clearance K000845 for MODIFICATION TO JMS A.V. FISTULA NEEDLE SET, Substantially Equivalent on 2000-04-10. Applicant: Jms Co., Ltd..

Clearance details

Applicant: Jms Co., Ltd.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2000-03-15
Decision date: 2000-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Hiroshima, JP

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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.