Cleared Traditional

K133155 - HYDROPHILIC COATED GUIDEWIRE

K133155 is an FDA 510(k) clearance for HYDROPHILIC COATED GUIDEWIRE, manufactured by Lake Region Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K133155 · Lake Region Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
172d
Days
Class 2
Risk

K133155 is an FDA 510(k) clearance for the HYDROPHILIC COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on April 7, 2014 after a review of 172 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. 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 Lake Region Medical devices

FDA 510(k) Submission Details - K133155

510(k) Number K133155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date April 07, 2014
Days to Decision 172 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 125d · This submission: 172d
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 521
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K133155.
HI-TORQUE VERSATURN GUIDE WIRE
K141782 · Abbott Vascular · Aug 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
K140695 · Medtronic, Inc. · Jun 2014
INSERTION TOOL
K140673 · Boston Scientific Corp · Apr 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865 · Asahi Intecc Co., Ltd. · Mar 2014
VDRIVE WITH V-SONO
K133396 · Stereotaxis, Inc. · Feb 2014
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
K132623 · Medtronic · Dec 2013