Cleared Traditional

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

K163316 · Carefusion 303, Inc. · Cardiovascular
Jun 2017
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K163316 is an FDA 510(k) clearance for the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Carefusion 303, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on June 22, 2017, 211 days after receiving the submission on November 23, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K163316 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2016
Decision Date June 22, 2017
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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