Cleared Traditional

Prelude Guide Sheath

K211405 · Merit Medical Systems, Inc. · Cardiovascular
Oct 2021
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K211405 is an FDA 510(k) clearance for the Prelude Guide Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 4, 2021, 151 days after receiving the submission on May 6, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K211405 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2021
Decision Date October 04, 2021
Days to Decision 151 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