ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC— 510(k) K090428

Substantially Equivalent

Genesee Biomedical, Inc.

FDA 510(k) clearance K090428 for ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC, Substantially Equivalent on 2009-05-07. Applicant: Genesee Biomedical, Inc..

Clearance details

Applicant: Genesee Biomedical, Inc.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2009-02-19
Decision date: 2009-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Denver, CO, 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.