CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R— 510(k) K061127

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K061127 for CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R, Substantially Equivalent on 2006-05-23. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2006-04-24
Decision date: 2006-05-23
Decision: Substantially Equivalent
Clearance type: Special
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.