K081515

Substantially Equivalent

NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0

Applicant: Neomed, Inc.
Product code: FOS
Advisory panel: General Hospital
Date received: 2008-05-30
Decision date: 2008-07-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Swanee, GA, 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.