DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED— 510(k) K914602

Substantially Equivalent

The Heart Valve Div. Medtronic Cardiovascular Surg

FDA 510(k) clearance K914602 for DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED, Substantially Equivalent on 1991-11-22. Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg.

Clearance details

Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 1991-10-15
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.