3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS— 510(k) K022287

Name: FDA 510(k) clearance K022287
Creator: U.S. Food and Drug Administration
Published: 2002-09-23

Substantially Equivalent

3t Medical Systems, LLC

FDA 510(k) clearance K022287 for 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS, Substantially Equivalent on 2002-09-23. Applicant: 3t Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: 3t Medical Systems, LLC
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2002-07-15
Decision date: 2002-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conifer, CO, US

Download summary PDF View on FDA.gov ↗

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K020768 — 3T VESSEL CANNULAS2002-08-23
K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE2002-05-03
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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.