K961336

Substantially Equivalent

MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652

Applicant
Medtronic PS Medical
Product code
LJS
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Goleta, CA, 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.