ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800— 510(k) K023185

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K023185 for ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800, Substantially Equivalent on 2002-12-17. Applicant: Sulzer Carbomedics, Inc..

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2002-09-24
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.