K091213

Substantially Equivalent

FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN

Applicant: Footprint Medical
Product code: FOS
Advisory panel: General Hospital
Date received: 2009-04-27
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.