Cleared Special

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

K091268 · Hospira, Inc. · Cardiovascular
Sep 2009
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K091268 is an FDA 510(k) clearance for the HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS, a Catheter, Oximeter, Fiber-optic (Class II — Special Controls, product code DQE), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on September 18, 2009, 141 days after receiving the submission on April 30, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number K091268 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2009
Decision Date September 18, 2009
Days to Decision 141 days
Submission Type Special
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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