DeviceClearance

K961752

Substantially Equivalent

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

Applicant
Ackrad Laboratories
Product code
LKF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cranford, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF
Malfunction
643
Other
2
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.