DeviceClearance

K023185

Substantially Equivalent

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

Applicant
Sulzer Carbomedics, Inc.
Product code
KRH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, 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.