Cleared Traditional

K072552 - MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE

K072552 is an FDA 510(k) clearance for MERIT MEDICAL SYSTEMS, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K072552 · Merit Medical Systems, Inc. · Cardiovascular device
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Dec 2007
Decision
95d
Days
Class 2
Risk

K072552 is an FDA 510(k) clearance for the MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 14, 2007 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 - K072552

510(k) Number K072552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date December 14, 2007
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K072552.
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K072705 · Asahi Intecc Co., Ltd. · Oct 2007
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K072431 · Asahi Intecc Co., Ltd. · Sep 2007
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K071029 · Stereotaxis, Inc. · Aug 2007