Cleared Traditional

ULTRASKIN HYDROPHILIC GUIDE WIRE (K141707) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141707 · Lepu Medical Technology (Beijing) Co., Ltd. · Cardiovascular device
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Jan 2015
Decision
211d
Days
Class 2
Risk

K141707 is an FDA 510(k) clearance for the ULTRASKIN HYDROPHILIC GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lepu Medical Technology (Beijing) Co., Ltd. (South Euclid, US). The FDA issued a Cleared decision on January 21, 2015 after a review of 211 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 Lepu Medical Technology (Beijing) Co., Ltd. devices

Submission Details

510(k) Number K141707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2014
Decision Date January 21, 2015
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 343
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K141707.
R350 guidewire
K151234 · Vascular Solutions, Inc. · Nov 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · Cook Incorporated · May 2015
Attain Hybrid Guide Wire
K143316 · Medtronic, Inc. · Mar 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
K143587 · Boston Scientific Corporation · Jan 2015
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · Merit Medical Systems, Inc. · Dec 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295 · Merit Medical Systems, Inc. · Dec 2014