K951738

Substantially Equivalent

ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER

Applicant: Sherwood Medical Co.
Product code: FOS
Advisory panel: General Hospital
Date received: 1995-04-14
Decision date: 1995-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.