MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE— 510(k) K860449

Substantially Equivalent

Top Corp.

FDA 510(k) clearance K860449 for MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE, Substantially Equivalent on 1986-02-26. Applicant: Top Corp..

Clearance details

Applicant: Top Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1986-02-04
Decision date: 1986-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, 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.