Cleared Traditional

K041740 - SILICONE COATED GUIDEWIRE

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

K041740 · Arrow International, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K041740

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
Combination Product No
PCCP Authorized No
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.

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 662
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K041740.
TORAYGUIDE GUIDEWIRE
K042370 · Toray Industries (America), Inc. · Dec 2004
GUIDEWIRES
K042264 · Rocket Medical Plc · Nov 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · Lake Region Mfg., Inc. · Sep 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973 · Intra Luminal Therapeutics, Inc. · Aug 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · Asahi Intecc Co., Ltd. · Aug 2004