Cleared Traditional

PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER

K140129 · Icu Medical, Inc. · Cardiovascular
Jul 2014
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K140129 is an FDA 510(k) clearance for the PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER, a Catheter, Oximeter, Fiber-optic (Class II — Special Controls, product code DQE), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 2, 2014, 167 days after receiving the submission on January 16, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number K140129 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2014
Decision Date July 02, 2014
Days to Decision 167 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQE — Catheter, Oximeter, Fiber-optic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1230

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