DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR— 510(k) K071049

Substantially Equivalent

Tyco Healthcare

FDA 510(k) clearance K071049 for DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR, Substantially Equivalent on 2007-10-16. Applicant: Tyco Healthcare.

Clearance details

Applicant: Tyco Healthcare
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2007-04-13
Decision date: 2007-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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, 2020-01-01 through 2026-04-23. 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.