Cleared Traditional

Edwards eSheath Introducer Set

K152225 · Edwards Lifesciences · Cardiovascular
Nov 2015
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K152225 is an FDA 510(k) clearance for the Edwards eSheath 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 November 24, 2015, 109 days after receiving the submission on August 7, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K152225 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2015
Decision Date November 24, 2015
Days to Decision 109 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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