Cleared Traditional

K231246 - Ventrax Delivery System (VTR851)

K231246 is the FDA 510(k) clearance for Ventrax Delivery System (VTR851) by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K231246 · Merit Medical Systems, Inc. · Cardiovascular device
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Aug 2023
Decision
121d
Days
Class 2
Risk

K231246 is an FDA 510(k) clearance for the Ventrax™ Delivery System (VTR851). 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 August 30, 2023 after a review of 121 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K231246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date August 30, 2023
Days to Decision 121 days
Submission Type Traditional
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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 581
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K231246.
Paragon 8F Balloon Guide Catheter
K232437 · Wallaby Medical · Oct 2023
Microcatheter
K232647 · Surmodics,Inc. · Sep 2023
Amulet™ Steerable Delivery Sheath
K232690 · Abbott Medical · Sep 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · Medtronic Vascular · Aug 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633 · Boston Scientific Corporation · Aug 2023
R2P Navicross
K231044 · Terumo Medical Corporation · Jul 2023