Cleared Special

FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER

K120304 · Footprint Medical, Inc. · General Hospital
Mar 2012
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K120304 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Footprint Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 1, 2012, 29 days after receiving the submission on February 1, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K120304 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2012
Decision Date March 01, 2012
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FOS — Catheter, Umbilical Artery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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