PUIG MASSANA-SHILEY ANNULOPLASTY RING— 510(k) K821261

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K821261 for PUIG MASSANA-SHILEY ANNULOPLASTY RING, Substantially Equivalent on 1982-06-16. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 1982-05-03
Decision date: 1982-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.