DeviceClearance

K771495

Substantially Equivalent

A.V. FISTULA NEEDLE SET (#361)

Applicant
Sorensen Research
Product code
FIE
Advisory panel
Gastroenterology, Urology
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 FIE

product code FIE
Death
2
Total
2

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.