MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER— 510(k) K120674

Unknown

Covidien

FDA 510(k) clearance K120674 for MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER, Unknown on 2012-04-04. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2012-03-05
Decision date: 2012-04-04
Decision: Unknown
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.