K810657

Substantially Equivalent

TEMPTRON #'S 6804/6805

Applicant
Medtronic Vascular
Product code
LDF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LDF

product code LDF
Death
19
Injury
188
Malfunction
694
Other
1
Total
902

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.