Cleared Special

K242873 - Ventrax™ Delivery System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242873 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (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.

View all Merit Medical Systems, Inc. devices

Submission Details

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.

Device Classification

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 887
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K242873.
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