K222170

Substantially Equivalent

Power Acute Triple Lumen Hemodialysis Catheter

Applicant
Health Line International Corporation
Product code
NIE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Slat Lake City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NIE

product code NIE
Death
9
Other
1
Total
10

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.