K892915

Substantially Equivalent

PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION

Applicant
Deknatel, Inc.
Product code
KDQ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose-Heredia, CR
Download summary PDF View on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ
Death
8
Malfunction
637
Total
645

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.