Cleared Traditional

K170532 - True Form Reshapable Guide Wire

K170532 is an FDA 510(k) clearance for True Form Reshapable Guide Wire, 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 149-day FDA review.

K170532 · Merit Medical Systems, Inc. · Cardiovascular device
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Jul 2017
Decision
149d
Days
Class 2
Risk

K170532 is an FDA 510(k) clearance for the True Form Reshapable Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on July 21, 2017 after a review of 149 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 - K170532

510(k) Number K170532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2017
Decision Date July 21, 2017
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 588
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K170532.
WATCHDOG Hemostasis Valve Kit
K172453 · Boston Scientific Corporation · Nov 2017
Hi-Torque Command 18 Guide Wire
K172073 · Abbott Vascular · Aug 2017
Approach CTO Microwire Guide
K171897 · Cook Incorporated · Aug 2017
Merit Hydrophilic Guide Wire
K170933 · Merit Medical Systems, Inc. · Jun 2017
Inqwire Diagnostic Guide Wire
K170700 · Merit Medical Systems, Inc. · Apr 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
K163426 · Asahi Intecc Co., Ltd. · Apr 2017