FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN— 510(k) K091213

Name: FDA 510(k) clearance K091213
Creator: U.S. Food and Drug Administration
Published: 2009-09-25

Substantially Equivalent

Footprint Medical

FDA 510(k) clearance K091213 for FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN, Substantially Equivalent on 2009-09-25. Applicant: Footprint Medical. Device class: 2.

Clearance details

Applicant: Footprint Medical
Product code: Code FOS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2009-04-27
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K093026 — FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER2010-02-24
K091488 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C2009-09-14
K090576 — FOOTPRINT URINARY DRAINAGE CATHETER2009-08-12
K090559 — FOOTPRINT MEDICAL SILICONE FEEDING TUBE2009-05-04

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.