Cleared Traditional

K173548 - Merit Pursue Microcatheter

K173548 is an FDA 510(k) clearance for Merit Pursue Microcatheter, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K173548 · Merit Medical Systems, Inc. · Cardiovascular device
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Mar 2018
Decision
134d
Days
Class 2
Risk

K173548 is an FDA 510(k) clearance for the Merit Pursue Microcatheter. 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 March 30, 2018 after a review of 134 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

FDA 510(k) Submission Details - K173548

510(k) Number K173548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2017
Decision Date March 30, 2018
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 646
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K173548.
Wingman 35 Crossing Catheter
K173661 · Reflow Medical, Inc. · Apr 2018
Wedge Microcatheter
K172014 · MicroVention, Inc. · Apr 2018
TrapLiner catheter
K180088 · Vascular Solutions, Inc. · Apr 2018
NaviCross 0.018
K173799 · Terumo Corporation · Mar 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709 · Inneuroco, Inc. · Jan 2018
Microcatheter
K173560 · Surmodics,Inc. · Jan 2018