Cleared Traditional

Swan Ganz Catheters

K160084 · Edwards Lifesciences, LLC · Cardiovascular
May 2016
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K160084 is an FDA 510(k) clearance for the Swan Ganz Catheters, a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 3, 2016, 109 days after receiving the submission on January 15, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K160084 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2016
Decision Date May 03, 2016
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYG — Catheter, Flow Directed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1240

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