TruForm Sievers Annuloplasty Ring— 510(k) K202253

Substantially Equivalent

Genesee Biomedical, Inc.

FDA 510(k) clearance K202253 for TruForm Sievers Annuloplasty Ring, Substantially Equivalent on 2020-10-06. Applicant: Genesee Biomedical, Inc..

Clearance details

Applicant: Genesee Biomedical, Inc.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2020-08-10
Decision date: 2020-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, 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.