DeviceClearance

K800147

Substantially Equivalent

FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.

Applicant
Usifroid
Product code
KRH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, 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.