Cleared Traditional

Swan-Ganz catheter

K233824 · Edwards Lifesciences, LLC · Cardiovascular
Jun 2024
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K233824 is an FDA 510(k) clearance for the Swan-Ganz catheter, 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 June 6, 2024, 188 days after receiving the submission on December 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K233824 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2023
Decision Date June 06, 2024
Days to Decision 188 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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