DeviceClearance

K992664

Substantially Equivalent

TFX MEDICAL STYLET CATHETER

Applicant
Tfx Medical Group
Product code
DRB
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jeffrey, NH, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DRB

product code DRB
Death
36
Injury
562
Total
598

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.