MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE— 510(k) K062953

Substantially Equivalent

Medisystems Corp.

FDA 510(k) clearance K062953 for MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE, Substantially Equivalent on 2007-02-12. Applicant: Medisystems Corp..

Clearance details

Applicant: Medisystems Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2006-09-29
Decision date: 2007-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.