Cleared Special

K123609 - MERIT HYDROPHILIC GUIDE WIRE

K123609 is an FDA 510(k) clearance for MERIT HYDROPHILIC GUIDE WIRE, 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 56-day FDA review.

K123609 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
56d
Days
Class 2
Risk

K123609 is an FDA 510(k) clearance for the MERIT HYDROPHILIC GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Angleton, US). The FDA issued a Cleared decision on January 16, 2013 after a review of 56 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K123609

510(k) Number K123609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date January 16, 2013
Days to Decision 56 days
Submission Type Special
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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 755
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K123609.
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
K122590 · Terumo Medical Corporation · Mar 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707 · Cook, Inc. · Feb 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067 · Abbott Vascular, Inc. · Jan 2013
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
K121398 · Guidepath Medical, Inc. · Dec 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · Abbott Vascular, Inc. · Nov 2012
STINGRAY GUIDEWIRES
K122795 · Bridgepoint Medical · Nov 2012
K123609 · MERIT HYDROPHILIC GUIDE WIRE
Download PDF FDA Summary Merit Medical Systems…