SIMPLICI-T ANNULOPLASTY SYSTEM— 510(k) K052970

Name: FDA 510(k) clearance K052970
Creator: U.S. Food and Drug Administration
Published: 2006-01-11

Substantially Equivalent

Medtronic Heart Valves

FDA 510(k) clearance K052970 for SIMPLICI-T ANNULOPLASTY SYSTEM, Substantially Equivalent on 2006-01-11. Applicant: Medtronic Heart Valves. Device class: 2.

Clearance details

Applicant: Medtronic Heart Valves
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2005-10-24
Decision date: 2006-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, 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.