Cleared Traditional

Swan-Ganz Catheters

K193466 · Edwards Lifesciences, LLC · Cardiovascular
Feb 2020
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K193466 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 February 16, 2020, 62 days after receiving the submission on December 16, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K193466 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2019
Decision Date February 16, 2020
Days to Decision 62 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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