Cleared Special

OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN

K062999 · Hospira, Inc. · Cardiovascular
Nov 2006
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K062999 is an FDA 510(k) clearance for the OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN, 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 November 3, 2006, 32 days after receiving the submission on October 2, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1230.

Submission Details

510(k) Number K062999 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2006
Decision Date November 03, 2006
Days to Decision 32 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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