Cleared Traditional

EPi-Ease Epicardial Access Device (EAS)

K233959 · AtriCure, Inc. · Cardiovascular
Feb 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K233959 is an FDA 510(k) clearance for the EPi-Ease Epicardial Access Device (EAS), a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on February 13, 2024, 60 days after receiving the submission on December 15, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K233959 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2023
Decision Date February 13, 2024
Days to Decision 60 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