K851005

Substantially Equivalent

XRO UMBILICAL CATHETER-CODE 270

Applicant: Vygon Corp.
Product code: FOS
Advisory panel: General Hospital
Date received: 1985-03-12
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Rutherford, NJ, 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.