FOOTPRINT URINARY DRAINAGE CATHETER— 510(k) K090576

Name: FDA 510(k) clearance K090576
Creator: U.S. Food and Drug Administration
Published: 2009-08-12

Substantially Equivalent

Footprint Medical

FDA 510(k) clearance K090576 for FOOTPRINT URINARY DRAINAGE CATHETER, Substantially Equivalent on 2009-08-12. Applicant: Footprint Medical. Device class: 2.

Clearance details

Applicant: Footprint Medical
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2009-03-03
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER2009-09-25
K091488 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C2009-09-14
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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.