Cleared Traditional

Edwards eSheath Introducer Set

K200258 · Edwards Lifesciences · Cardiovascular
Mar 2020
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K200258 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 March 9, 2020, 35 days after receiving the submission on February 3, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K200258 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2020
Decision Date March 09, 2020
Days to Decision 35 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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