Cleared Special

Prelude Wave Hydrophilic Sheath Introducer

K250909 · Merit Medical Systems, Inc. · Cardiovascular
Apr 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250909 is an FDA 510(k) clearance for the Prelude Wave Hydrophilic Sheath Introducer, 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 April 25, 2025, 30 days after receiving the submission on March 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K250909 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2025
Decision Date April 25, 2025
Days to Decision 30 days
Submission Type Special
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