DeviceClearance

K002868

Substantially Equivalent

BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER

Applicant
C.R. Bard, Inc.
Product code
EZL
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Covington, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL
Death
6
Injury
796
Malfunction
4,989
Other
1
Total
5,792

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.