Cleared Traditional

K123067 - PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY

K123067 is an FDA 510(k) clearance for PROGRESS GUIDE WIRE FAMILY, manufactured by Abbott Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K123067 · Abbott Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
120d
Days
Class 2
Risk

K123067 is an FDA 510(k) clearance for the PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Temecula, US). The FDA issued a Cleared decision on January 29, 2013 after a review of 120 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 Abbott Vascular, Inc. devices

FDA 510(k) Submission Details - K123067

510(k) Number K123067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date January 29, 2013
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01435031 Completed Interventional Industry-sponsored

EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

250
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Coronary Artery Disease (CAD); Chronic Total Occlusion (CTO)
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator David E. Kandzari, MD
Sponsor Abbott Medical Devices (industry)
Started 2011-09-01 → Primary completion 2014-02-01 → Completed 2017-12-01
Primary outcome
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)
Secondary outcome
Minimum Lumen Diameter (MLD): Pre-procedure
View full study on ClinicalTrials.gov

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 K123067.
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
K124007 · Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · Mar 2013
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
K122590 · Terumo Medical Corporation · Mar 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707 · Cook, Inc. · Feb 2013
MERIT HYDROPHILIC GUIDE WIRE
K123609 · Merit Medical Systems, 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