K130725

Substantially Equivalent

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.

Applicant: Covidien Lp, Formerly Registered AS Kendall
Product code: FOS
Advisory panel: General Hospital
Date received: 2013-03-18
Decision date: 2013-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.