Cleared Traditional

OPTICATH CENTRAL VENOUS OXIMETRY CATHETER

K061585 · Hospira, Inc. · Cardiovascular
Oct 2006
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K061585 is an FDA 510(k) clearance for the OPTICATH CENTRAL VENOUS OXIMETRY CATHETER, 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 October 5, 2006, 120 days after receiving the submission on June 7, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number K061585 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2006
Decision Date October 05, 2006
Days to Decision 120 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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