Cleared Special

K242873 - Ventrax™ Delivery System

K242873 is an FDA 510(k) clearance for Ventrax Delivery System, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 114-day FDA review.

K242873 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
114d
Days
Class 2
Risk

K242873 is an FDA 510(k) clearance for the Ventrax™ Delivery System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 15, 2025 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K242873

510(k) Number K242873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K242873.
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K242588 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jan 2025
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K243224 · Abbott Medical · Dec 2024
SENDERO MAX Delivery Catheter
K242644 · Okami Medical, Inc. · Dec 2024
K242873 · Ventrax™ Delivery System
Download PDF FDA Summary Merit Medical Systems…