STRAIGHT AND BUBBLE OXYGEN TUBING— 510(k) K844083

Name: FDA 510(k) clearance K844083
Creator: U.S. Food and Drug Administration
Published: 1984-10-30

Substantially Equivalent

Hudson Extrusions, Inc.

FDA 510(k) clearance K844083 for STRAIGHT AND BUBBLE OXYGEN TUBING, Substantially Equivalent on 1984-10-30. Applicant: Hudson Extrusions, Inc.. Device class: 1.

Clearance details

Applicant: Hudson Extrusions, Inc.
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1984-10-19
Decision date: 1984-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, OH, US

Download summary PDF View on FDA.gov ↗

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K844084 — POLYVINYL CHLORIDE CANNULAS1984-10-30

Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.