Cleared Traditional

K041740 - SILICONE COATED GUIDEWIRE

K041740 is the FDA 510(k) clearance for SILICONE COATED GUIDEWIRE by Arrow International, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K041740 · Arrow International, Inc. · Cardiovascular device
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Oct 2004
Decision
109d
Days
Class 2
Risk

K041740 is an FDA 510(k) clearance for the SILICONE COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on October 15, 2004 after a review of 109 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 Arrow International, Inc. devices

Submission Details

510(k) Number K041740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2004
Decision Date October 15, 2004
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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 455
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K041740.
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · Asahi Intecc Co., Ltd. · Jan 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · Asahi Intecc Co., Ltd. · Aug 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · Boston Scientific Corp · Apr 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · Arrow Intl., Inc. · Mar 2004