Cleared Special

Ventrax? Delivery System

K242873 · Merit Medical Systems, Inc. · Cardiovascular
Jan 2025
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K242873 is an FDA 510(k) clearance for the Ventrax? Delivery System, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 15, 2025, 114 days after receiving the submission on September 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K242873 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2024
Decision Date January 15, 2025
Days to Decision 114 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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