NEOMED SINGLE LUMEN UMBILICAL CATHETER— 510(k) K073596

Substantially Equivalent

Neomed, Inc.

FDA 510(k) clearance K073596 for NEOMED SINGLE LUMEN UMBILICAL CATHETER, Substantially Equivalent on 2008-02-22. Applicant: Neomed, Inc..

Clearance details

Applicant: Neomed, Inc.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 2007-12-21
Decision date: 2008-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Swanee, GA, 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.