FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER— 510(k) K091214

Substantially Equivalent

Footprint Medical

FDA 510(k) clearance K091214 for FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, Substantially Equivalent on 2009-09-25. Applicant: Footprint Medical.

Clearance details

Applicant: Footprint Medical
Product code: 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

Download summary PDF View on FDA.gov ↗

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.