VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH— 510(k) K921352

Name: FDA 510(k) clearance K921352
Creator: U.S. Food and Drug Administration
Published: 1992-10-26

Substantially Equivalent

Vygon Corp.

FDA 510(k) clearance K921352 for VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH, Substantially Equivalent on 1992-10-26. Applicant: Vygon Corp.. Device class: 2.

Clearance details

Applicant: Vygon Corp.
Product code: Code FOS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1992-03-19
Decision date: 1992-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, NJ, US

Download summary PDF View on FDA.gov ↗

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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.