K895662

Substantially Equivalent

DEFIB K-PADS

Applicant
Katecho, Inc.
Product code
LDD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Des Moines, IA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD
Death
38
Malfunction
522
Total
560

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.