ANNULOFLO SYSTEM, MITRAL MODEL AR700— 510(k) K021051

Name: FDA 510(k) clearance K021051
Creator: U.S. Food and Drug Administration
Published: 2002-04-23

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K021051 for ANNULOFLO SYSTEM, MITRAL MODEL AR700, Substantially Equivalent on 2002-04-23. Applicant: Sulzer Carbomedics, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2002-04-01
Decision date: 2002-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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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.