Cleared Traditional

EDWARDS ESHEATH INTRODUCER SET

K141696 · Edwards Lifesciences · Cardiovascular
Sep 2014
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K141696 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 September 18, 2014, 86 days after receiving the submission on June 24, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K141696 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2014
Decision Date September 18, 2014
Days to Decision 86 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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