BIONICS ARTERIAL/VENOUS FISTULA NEEDLE— 510(k) K801354

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K801354 for BIONICS ARTERIAL/VENOUS FISTULA NEEDLE, Substantially Equivalent on 1980-07-08. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1980-06-09
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.