UMBILICAL VESSEL CATHETER— 510(k) K840339

Name: FDA 510(k) clearance K840339
Creator: U.S. Food and Drug Administration
Published: 1984-07-25

Substantially Equivalent

Catheter Technology Corp.

FDA 510(k) clearance K840339 for UMBILICAL VESSEL CATHETER, Substantially Equivalent on 1984-07-25. Applicant: Catheter Technology Corp.. Device class: 2.

Clearance details

Applicant: Catheter Technology Corp.
Product code: Code FOS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1984-01-25
Decision date: 1984-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN2009-09-25
K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER2009-09-25

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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.