K070613

Substantially Equivalent

ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT

Applicant
AngioDynamics, Inc.
Product code
LJS
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Queensburgy, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

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.