Cleared Special

K140608 - MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE

K140608 is an FDA 510(k) clearance for MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC..., manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 186-day FDA review.

K140608 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
186d
Days
Class 2
Risk

K140608 is an FDA 510(k) clearance for the MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE. 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 September 12, 2014 after a review of 186 days - an extended review cycle.

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

FDA 510(k) Submission Details - K140608

510(k) Number K140608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2014
Decision Date September 12, 2014
Days to Decision 186 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Modification to existing cleared device.

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 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K140608.
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K140608 · MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
Download PDF FDA Summary Merit Medical Systems…