DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE— 510(k) K032810

Name: FDA 510(k) clearance K032810
Creator: U.S. Food and Drug Administration
Published: 2003-12-05

Substantially Equivalent

Medtronic Heart Valves

FDA 510(k) clearance K032810 for DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE, Substantially Equivalent on 2003-12-05. 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: 2003-09-09
Decision date: 2003-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
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.