COMPACTCATH INTERMITTENT URINARY CATHETER— 510(k) K140945

Name: FDA 510(k) clearance K140945
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Substantially Equivalent

Compactcath, Inc.

FDA 510(k) clearance K140945 for COMPACTCATH INTERMITTENT URINARY CATHETER, Substantially Equivalent on 2014-08-22. Applicant: Compactcath, Inc.. Device class: 2.

Clearance details

Applicant: Compactcath, Inc.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2014-04-14
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lutsen, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.