IONESCU-SHILEY AORTIC GRAFT VALVE— 510(k) K803000

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K803000 for IONESCU-SHILEY AORTIC GRAFT VALVE, Substantially Equivalent on 1981-02-02. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1980-11-25
Decision date: 1981-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.