DeviceClearance

K230679

Substantially Equivalent

WellsForm Tricuspid Annuloplasty Band (WF)

Applicant
Genesee Biomedical, Inc.
Product code
KRH
Advisory panel
Cardiovascular
Date received
Decision date
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, through . 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.