Cleared Traditional

Swang-Ganz IQ pulmonary artery catheter

K222117 · Edwards Lifesiences, LLC · Cardiovascular
Dec 2022
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K222117 is an FDA 510(k) clearance for the Swang-Ganz IQ pulmonary artery catheter, a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Edwards Lifesiences, LLC (Irvine, US). The FDA issued a Cleared decision on December 9, 2022, 144 days after receiving the submission on July 18, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K222117 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2022
Decision Date December 09, 2022
Days to Decision 144 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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