VYGON DOUBLE LUMEN UMBILICAL CATHETER— 510(k) K981630

Substantially Equivalent

Schiff & Co.

FDA 510(k) clearance K981630 for VYGON DOUBLE LUMEN UMBILICAL CATHETER, Substantially Equivalent on 1998-10-01. Applicant: Schiff & Co..

Clearance details

Applicant: Schiff & Co.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.