Cleared Traditional

Edwards eSheath Optima introducer set

K244046 · Edwards Lifesciences · Cardiovascular
Mar 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K244046 is an FDA 510(k) clearance for the Edwards eSheath Optima introducer set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on March 27, 2025, 87 days after receiving the submission on December 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K244046 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2024
Decision Date March 27, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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