SEGUIN ANNULOPLASTY RING— 510(k) K092310

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K092310 for SEGUIN ANNULOPLASTY RING, Substantially Equivalent on 2009-08-27. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2009-07-29
Decision date: 2009-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: St.Paul, MN, US

Download summary PDF View on FDA.gov ↗

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.