FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER— 510(k) K120304

Substantially Equivalent

Footprint Medical, Inc.

FDA 510(k) clearance K120304 for FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER, Substantially Equivalent on 2012-03-01. Applicant: Footprint Medical, Inc..

Clearance details

Applicant: Footprint Medical, Inc.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 2012-02-01
Decision date: 2012-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

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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.