TERUMO AV FISTULA NEEDLE SET— 510(k) K891062

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K891062 for TERUMO AV FISTULA NEEDLE SET, Substantially Equivalent on 1989-06-22. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-01
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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.