K981630

Substantially Equivalent

VYGON DOUBLE LUMEN UMBILICAL CATHETER

Applicant: Schiff & Co.
Product code: FOS
Advisory panel: General Hospital
Date received: 1998-05-07
Decision date: 1998-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, 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.