UMBILI-CATH CATHETER— 510(k) K802414

Name: FDA 510(k) clearance K802414
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Int'L Corp.

FDA 510(k) clearance K802414 for UMBILI-CATH CATHETER, Substantially Equivalent on 1980-10-23. Applicant: Int'L Corp.. Device class: 2.

Clearance details

Applicant: Int'L Corp.
Product code: Code FOS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1980-10-03
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K201697 — Umbilical Vessels Catheter2021-05-06
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K120304 — FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER2012-03-01
K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN2009-09-25
K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER2009-09-25

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K842995 — EMA LIV CENERA DENTAL CEMENT1984-10-30
K842994 — EMA FREEGENOL DENTAL CEMENT1984-10-18
K821814 — HEMO-NATE L-P KIT1982-07-09

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.