SHELLY PROTECTED AV FISTULA NEEDLE— 510(k) K992653

Substantially Equivalent

Diasol, Inc.

FDA 510(k) clearance K992653 for SHELLY PROTECTED AV FISTULA NEEDLE, Substantially Equivalent on 1999-10-27. Applicant: Diasol, Inc..

Clearance details

Applicant: Diasol, Inc.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-06
Decision date: 1999-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Hollywood, CA, 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.