Cleared Traditional

FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER

K091214 · Footprint Medical · General Hospital
Sep 2009
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K091214 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on September 25, 2009, 151 days after receiving the submission on April 27, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K091214 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2009
Decision Date September 25, 2009
Days to Decision 151 days
Submission Type Traditional
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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