Cleared Traditional

NEOMED SINGLE LUMEN UMBILICAL CATHETER

K073596 · Neomed, Inc. · General Hospital
Feb 2008
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K073596 is an FDA 510(k) clearance for the NEOMED SINGLE LUMEN UMBILICAL CATHETER, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on February 22, 2008, 63 days after receiving the submission on December 21, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K073596 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2007
Decision Date February 22, 2008
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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